Trial Outcomes & Findings for A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (NCT NCT01691898)

NCT ID: NCT01691898

Last Updated: 2020-02-21

Results Overview

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (\>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a \>/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

231 participants

Primary outcome timeframe

Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)

Results posted on

2020-02-21

Participant Flow

A total of 289 participants were screened, out of which, 231 participants were enrolled into the study.

Participant milestones

Participant milestones
Measure
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m\^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Overall Study
STARTED
63
59
20
9
40
40
Overall Study
COMPLETED
16
15
11
4
26
5
Overall Study
NOT COMPLETED
47
44
9
5
14
35

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m\^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Overall Study
Death
34
32
6
3
8
31
Overall Study
Adverse Event
0
1
0
1
1
0
Overall Study
Progression of Disease
1
2
1
0
0
1
Overall Study
Lost to Follow-up
3
1
0
0
1
0
Overall Study
Withdrawal by Subject
9
8
2
1
3
3
Overall Study
Non-Compliance
0
0
0
0
1
0

Baseline Characteristics

A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=63 Participants
Participants with relapsed or refractory \[r/r\] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m\^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
n=59 Participants
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
n=9 Participants
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=40 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=40 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Total
n=231 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
n=5 Participants
25 Participants
n=7 Participants
12 Participants
n=5 Participants
4 Participants
n=4 Participants
23 Participants
n=21 Participants
16 Participants
n=8 Participants
109 Participants
n=8 Participants
Age, Categorical
>=65 years
34 Participants
n=5 Participants
34 Participants
n=7 Participants
8 Participants
n=5 Participants
5 Participants
n=4 Participants
17 Participants
n=21 Participants
24 Participants
n=8 Participants
122 Participants
n=8 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
24 Participants
n=7 Participants
8 Participants
n=5 Participants
2 Participants
n=4 Participants
16 Participants
n=21 Participants
18 Participants
n=8 Participants
95 Participants
n=8 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
35 Participants
n=7 Participants
12 Participants
n=5 Participants
7 Participants
n=4 Participants
24 Participants
n=21 Participants
22 Participants
n=8 Participants
136 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
10 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants
n=5 Participants
44 Participants
n=7 Participants
19 Participants
n=5 Participants
9 Participants
n=4 Participants
33 Participants
n=21 Participants
36 Participants
n=8 Participants
189 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
13 Participants
n=5 Participants
10 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
7 Participants
n=21 Participants
2 Participants
n=8 Participants
32 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (\>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a \>/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=42 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
53.8 percentage of participants
Interval 39.58 to 67.65
70.0 percentage of participants
Interval 49.22 to 86.04
59.5 percentage of participants
Interval 45.67 to 72.32
61.9 percentage of participants
Interval 41.72 to 79.43
75.0 percentage of participants
Interval 54.44 to 89.59

PRIMARY outcome

Timeframe: First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a \>/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=21 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=14 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=25 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=13 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
13.37 months
Interval 0.03 to 35.68
9.36 months
Interval 0.03 to 19.35
6.24 months
Interval 0.89 to 22.57
6.47 months
Interval 0.03 to 23.52
12.85 months
Interval 0.03 to 22.11

PRIMARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to \[\</=\] mediastinum), or 3 (uptake less than \[\<\] mediastinum but \</=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=34 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=27 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=4 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=2 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H
35.3 percentage of participants
Interval 21.79 to 50.82
0 percentage of participants
Interval 0.0 to 10.5
0 percentage of participants
Interval 0.0 to 52.71
50.0 percentage of participants
Interval 2.53 to 97.47

SECONDARY outcome

Timeframe: Baseline, post-baseline (up to approximately 5.5 years)

Population: Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.

Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=60 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=1 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin
Baseline
2 participants
Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin
Post-baseline
0 participants
0 participants

SECONDARY outcome

Timeframe: Baseline, post-baseline (up to approximately 5.5 years)

Population: Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.

Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=8 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=2 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=59 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=37 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=36 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Number of Participants With ADA to Polatuzumab Vedotin
Baseline
0 participants
0 participants
1 participants
0 participants
0 participants
Number of Participants With ADA to Polatuzumab Vedotin
Post-baseline
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Baseline, post-baseline (up to approximately 5.5 years)

Population: Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.

Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=9 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=37 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Number of Participants With ADA to Obinutuzumab
Baseline
0 participants
1 participants
2 participants
Number of Participants With ADA to Obinutuzumab
Post-baseline
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=42 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
76.9 percentage of participants
55.0 percentage of participants
85.7 percentage of participants
52.4 percentage of participants
60.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=42 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
5.552 months
Interval 4.304 to 12.78
15.277 months
Interval 12.189 to 25.133
5.388 months
Interval 3.943 to 10.579
12.682 months
Interval 8.936 to 27.466
18.103 months
Interval 11.598 to 30.259

SECONDARY outcome

Timeframe: Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.

Percentage of participants who died due to any cause was reported.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=42 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
61.5 percentage of participants
15.0 percentage of participants
66.7 percentage of participants
23.8 percentage of participants
20.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.

OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=42 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)
18.760 months
Interval 10.415 to 38.571
NA months
Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.
16.493 months
Interval 7.458 to 32.46
NA months
Interval 44.025 to
Median and Upper Limit of CI could not be estimated because very few participants (\<50%) had the event of interest.
NA months
Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=36 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=33 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=4 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=3 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
33.3 percentage of participants
Interval 20.49 to 48.34
15.2 percentage of participants
Interval 6.17 to 29.25
25.0 percentage of participants
Interval 1.27 to 75.14
66.7 percentage of participants
Interval 13.54 to 98.3

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=34 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=27 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=4 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=2 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
64.7 percentage of participants
Interval 49.18 to 78.21
18.5 percentage of participants
Interval 7.59 to 35.06
25.0 percentage of participants
Interval 1.27 to 75.14
100.0 percentage of participants
Interval 22.36 to 100.0

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately \>liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=36 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=33 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=4 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=3 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
63.9 percentage of participants
Interval 48.83 to 77.15
21.2 percentage of participants
Interval 10.4 to 36.18
25.0 percentage of participants
Interval 1.27 to 75.14
66.7 percentage of participants
Interval 13.54 to 98.3

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (\</=) 1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=31 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=36 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
6.5 percentage of participants
Interval 1.2 to 19.0
13.9 percentage of participants
Interval 5.6 to 27.0

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to \</=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=37 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=39 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
10.8 percentage of participants
Interval 3.8 to 23.1
20.5 percentage of participants
Interval 10.6 to 34.0

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to \</=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as \>/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least \>50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=31 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=36 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
25.8 percentage of participants
Interval 13.5 to 41.8
66.7 percentage of participants
Interval 51.7 to 79.5

SECONDARY outcome

Timeframe: 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to \</=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as \>/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least \>50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=37 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=39 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
21.6 percentage of participants
Interval 11.2 to 35.6
64.1 percentage of participants
Interval 49.7 to 76.8

SECONDARY outcome

Timeframe: Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)

Population: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately \>liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=5 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=4 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
74.4 percentage of participants
Interval 60.4 to 85.38
43.6 percentage of participants
Interval 30.0 to 57.94
20.0 percentage of participants
Interval 1.02 to 65.74
50.0 percentage of participants
Interval 9.76 to 90.24

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable pharmacokinetic (PK) concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=11 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=25 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
4200 day*micrograms (mcg)/milliliter (mL)
Standard Deviation 2620
3910 day*micrograms (mcg)/milliliter (mL)
Standard Deviation 2480
5640 day*micrograms (mcg)/milliliter (mL)
Standard Deviation 8320
3350 day*micrograms (mcg)/milliliter (mL)
Standard Deviation 1180
2660 day*micrograms (mcg)/milliliter (mL)
Standard Deviation 879

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=35 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=16 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=36 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=18 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=18 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
232 mcg/mL
Standard Deviation 72.7
228 mcg/mL
Standard Deviation 83.3
217 mcg/mL
Standard Deviation 61.5
225 mcg/mL
Standard Deviation 40.9
227 mcg/mL
Standard Deviation 32.4

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

CL for rituximab was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=11 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=25 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
116.26 mL/day/meter-square (m^2)
Standard Deviation 59.99
134.31 mL/day/meter-square (m^2)
Standard Deviation 97.45
113.97 mL/day/meter-square (m^2)
Standard Deviation 61.41
124.53 mL/day/meter-square (m^2)
Standard Deviation 41.12
158.57 mL/day/meter-square (m^2)
Standard Deviation 60.47

SECONDARY outcome

Timeframe: Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) \& 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, \& 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days).

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=11 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=25 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
25.6 days
Standard Deviation 18.0
19.8 days
Standard Deviation 7.34
35.3 days
Standard Deviation 56.3
18.7 days
Standard Deviation 6.23
14.4 days
Standard Deviation 3.62

SECONDARY outcome

Timeframe: Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)

Population: Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Vss for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) \& 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, \& 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=11 Participants
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=25 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
2988.90 mL/m^2
Standard Deviation 788.89
2839.26 mL/m^2
Standard Deviation 730.10
2901.85 mL/m^2
Standard Deviation 1009.31
2802.96 mL/m^2
Standard Deviation 678.33
2654.46 mL/m^2
Standard Deviation 413.19

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=27 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=15 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
309 day*mcg/mL
Standard Deviation 67.7
315 day*mcg/mL
Standard Deviation 111

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=17 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
2840 day*nanogram (ng)/mL
Standard Deviation 555
3110 day*nanogram (ng)/mL
Standard Deviation 828

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.

AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
34.2 day*ng/mL
Standard Deviation 24.0
33.5 day*ng/mL
Standard Deviation 17.5

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=20 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
42.5 mcg/mL
Standard Deviation 11.6
48.3 mcg/mL
Standard Deviation 9.34

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=38 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
850 ng/mL
Standard Deviation 222
994 ng/mL
Standard Deviation 190

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.

Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=21 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
4.39 ng/mL
Standard Deviation 3.15
4.20 ng/mL
Standard Deviation 2.32

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=17 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
412 day*mcg/mL
Standard Deviation 108
428 day*mcg/mL
Standard Deviation 106

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=30 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=17 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
3660 day*ng/mL
Standard Deviation 843
3510 day*ng/mL
Standard Deviation 1160

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.

AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=18 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
31.7 day*ng/mL
Standard Deviation 17.2
29.5 day*ng/mL
Standard Deviation 25.0

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=38 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=16 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
51.9 mcg/mL
Standard Deviation 12.3
55.9 mcg/mL
Standard Deviation 12.8

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=38 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=17 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
948 ng/mL
Standard Deviation 204
968 ng/mL
Standard Deviation 268

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.

Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=39 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=18 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
3.72 ng/mL
Standard Deviation 1.98
3.29 ng/mL
Standard Deviation 2.71

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=17 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
258 day*mcg/mL
Standard Deviation 84.1

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=15 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
2600 day*ng/mL
Standard Deviation 630

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.

AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
17.7 day*ng/mL
Standard Deviation 9.39

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=19 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
42.2 mcg/mL
Standard Deviation 7.92

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=17 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
787 ng/mL
Standard Deviation 113

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.

Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=20 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
2.02 ng/mL
Standard Deviation 1.34

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=27 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=30 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
218 day*mcg/mL
Standard Deviation 89.1
215 day*mcg/mL
Standard Deviation 102

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=26 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=29 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
2440 day*ng/mL
Standard Deviation 665
2340 day*ng/mL
Standard Deviation 875

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.

AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=40 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=41 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
27.9 day*ng/mL
Standard Deviation 21.3
22.3 day*ng/mL
Standard Deviation 9.46

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=37 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=38 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
35.0 mcg/mL
Standard Deviation 9.89
34.2 mcg/mL
Standard Deviation 7.89

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=33 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=33 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
711 ng/mL
Standard Deviation 155
694 ng/mL
Standard Deviation 161

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.

Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=40 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=41 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
3.62 ng/mL
Standard Deviation 3.73
2.80 ng/mL
Standard Deviation 1.30

SECONDARY outcome

Timeframe: Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

Population: Analysis was performed on all participants who received obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=40 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=35 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
340 mcg/mL
Standard Deviation 95.0
330 mcg/mL
Standard Deviation 87.9

SECONDARY outcome

Timeframe: Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.

OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=35 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=9 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
10.5 Months
Interval 5.5 to 16.7
NA Months
Interval 38.4 to
Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.

SECONDARY outcome

Timeframe: Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.

Percentage of participants who died due to any cause was reported.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=45 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=44 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
77.8 percentage of participants
20.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=45 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=44 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
2.7 months
Interval 2.1 to 5.9
19.5 months
Interval 10.9 to 38.4

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)

Population: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.

Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

Outcome measures

Outcome measures
Measure
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
n=45 Participants
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=44 Participants
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
88.9 percentage of participants
56.8 percentage of participants

Adverse Events

Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab

Serious events: 27 serious events
Other events: 63 other events
Deaths: 35 deaths

Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab

Serious events: 21 serious events
Other events: 58 other events
Deaths: 33 deaths

Cohort C (FL): RTX + Polatuzumab

Serious events: 8 serious events
Other events: 20 other events
Deaths: 6 deaths

Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab

Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths

Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab

Serious events: 9 serious events
Other events: 37 other events
Deaths: 8 deaths

Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab

Serious events: 18 serious events
Other events: 38 other events
Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=63 participants at risk
Participants with relapsed or refractory \[r/r\] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m\^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
n=59 participants at risk
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 participants at risk
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
n=9 participants at risk
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=40 participants at risk
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=40 participants at risk
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Blood and lymphatic system disorders
Coagulopathy
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Febrile neutropenia
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Thrombocytopenia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Atrial fibrillation
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Atrial flutter
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Cardiac failure
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Cardiac failure congestive
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Pericardial effusion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Colonic fistula
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Constipation
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Diarrhoea
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Duodenal perforation
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Dysphagia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Fistula of small intestine
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Gastric perforation
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Hernial eventration
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Nausea
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Pancreatitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Subileus
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Vomiting
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Axillary pain
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Chest discomfort
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Chest pain
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Fatigue
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
General physical health deterioration
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Malaise
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Non-cardiac chest pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Pyrexia
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Sudden death
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Cholangitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Hepatocellular injury
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Hepatomegaly
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Bronchitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Cellulitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Clostridial sepsis
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Clostridium difficile infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Device related infection
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Febrile infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Gastroenteritis
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Herpes zoster
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Influenza
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Lung infection
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Pneumonia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Sepsis
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Septic shock
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Sinusitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Upper respiratory tract infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Urinary tract infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Urosepsis
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Viral diarrhoea
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Subdural Haematoma
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Wound secretion
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Cachexia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Dehydration
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hyperglycaemia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Bone pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ganglioneuroma
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Cerebrovascular accident
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Syncope
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Acute kidney injury
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Chronic kidney disease
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Urinary retention
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Hypotension
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Orthostatic hypotension
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Hepatobiliary disorders
Liver Disorder
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.

Other adverse events

Other adverse events
Measure
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
n=63 participants at risk
Participants with relapsed or refractory \[r/r\] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m\^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m\^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
n=59 participants at risk
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m\^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Cohort C (FL): RTX + Polatuzumab
n=20 participants at risk
Participants with r/r FL received RTX at a dose of 375 mg/m\^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
n=9 participants at risk
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
n=40 participants at risk
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
n=40 participants at risk
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Infections and infestations
Sinusitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Tooth infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Upper respiratory tract infection
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Urinary tract infection
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Animal bite
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Contusion
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Fall
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Infusion related reaction
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Procedural pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Anaemia
14.3%
9/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
16.9%
10/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Neutropenia
30.2%
19/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.4%
15/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
40.0%
8/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
44.4%
4/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Blood and lymphatic system disorders
Thrombocytopenia
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Atrial fibrillation
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Cardiac tamponade
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Pericardial effusion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Cardiac disorders
Tachycardia
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Ear and labyrinth disorders
Ear discomfort
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Ear and labyrinth disorders
Ear pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Ear and labyrinth disorders
Vertigo
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Eye disorders
Dry eye
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Eye disorders
Eye pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Eye disorders
Lacrimation increased
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Eye disorders
Vision blurred
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Eye disorders
Visual impairment
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal discomfort
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal distension
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal pain
17.5%
11/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
18.6%
11/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal pain lower
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Abdominal pain upper
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Constipation
28.6%
18/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
23.7%
14/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.0%
5/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
35.0%
14/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Diarrhoea
44.4%
28/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
42.4%
25/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.0%
5/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
33.3%
3/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
32.5%
13/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
35.0%
14/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Dry mouth
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
8.5%
5/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Dyspepsia
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Dysphagia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Gastritis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Gastrointestinal pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Gastrooesophageal reflux disease
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Haemorrhoids
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Nausea
31.7%
20/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
42.4%
25/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
55.0%
11/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
27.5%
11/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
35.0%
14/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Toothache
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Gastrointestinal disorders
Vomiting
17.5%
11/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.0%
13/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Asthenia
17.5%
11/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
27.1%
16/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Chest pain
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Chills
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Fatigue
50.8%
32/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
57.6%
34/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
65.0%
13/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
55.6%
5/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
45.0%
18/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.5%
9/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Feeling hot
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Gait disturbance
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Influenza like illness
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Malaise
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Nodule
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Oedema peripheral
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Pain
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Peripheral swelling
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Pyrexia
23.8%
15/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.3%
9/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.0%
5/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
General disorders
Unevaluable event
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Immune system disorders
Hypogammaglobulinaemia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Immune system disorders
Seasonal allergy
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Candida infection
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Ear infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Gastroenteritis viral
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Herpes zoster
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Influenza
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Mucosal infection
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Oesophageal candidiasis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Oral candidiasis
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Oropharyngeal candidiasis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Otitis externa
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Pharyngitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Pilonidal cyst
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Rash pustular
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Rhinitis
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Alanine aminotransferase increased
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Aspartate aminotransferase increased
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Blood creatinine increased
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Blood potassium decreased
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Lipase increased
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Neutrophil count decreased
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Platelet count decreased
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Protein total decreased
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Weight decreased
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.9%
7/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
Weight increased
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Investigations
White blood cell count decreased
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Decreased appetite
20.6%
13/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
28.8%
17/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
4/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Dehydration
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Gout
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hypercalcaemia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hyperglycaemia
12.7%
8/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hyperuricaemia
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hypokalaemia
11.1%
7/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hypomagnesaemia
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hyponatraemia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Hypophosphataemia
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Arthralgia
14.3%
9/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
18.6%
11/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.0%
5/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Back pain
11.1%
7/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Bone pain
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Joint stiffness
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Muscle spasms
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Muscle tightness
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Muscular weakness
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
8.5%
5/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Myalgia
11.1%
7/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Musculoskeletal and connective tissue disorders
Pain in extremity
11.1%
7/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.3%
12/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
4/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Cluster headache
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Cognitive disorder
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Cubital tunnel syndrome
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Dizziness
11.1%
7/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
16.9%
10/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Dysgeusia
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Headache
15.9%
10/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
30.0%
6/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.0%
10/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Hypoaesthesia
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Memory impairment
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Nerve compression
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Neuropathy peripheral
36.5%
23/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
45.8%
27/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
30.0%
6/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Paraesthesia
7.9%
5/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Peripheral motor neuropathy
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
8.5%
5/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Peripheral sensory neuropathy
25.4%
16/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
28.8%
17/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
55.0%
11/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Restless legs syndrome
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Syncope
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Tremor
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Psychiatric disorders
Adjustment disorder with depressed mood
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Psychiatric disorders
Anxiety
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
8.5%
5/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Psychiatric disorders
Depression
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Psychiatric disorders
Hallucination olfactory
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Psychiatric disorders
Insomnia
23.8%
15/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
13.6%
8/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Dysuria
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Nocturia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Renal and urinary disorders
Urinary hesitation
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Cough
14.3%
9/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
25.4%
15/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Dysphonia
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.5%
11/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
18.6%
11/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
12.5%
5/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
8/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Epistaxis
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
3.4%
2/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Orthopnoea
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Productive cough
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
4/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
22.2%
2/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Actinic keratosis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Alopecia
15.9%
10/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.9%
7/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Brow ptosis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Dry skin
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Erythema
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Hyperhidrosis
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Night sweats
9.5%
6/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
6.8%
4/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
3/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
15.0%
6/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Pruritus
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.2%
6/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
2/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
17.5%
7/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
7.5%
3/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Rash pruritic
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Surgical and medical procedures
Thrombolysis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Flushing
1.6%
1/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Haematoma
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Hypertension
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Hypotension
6.3%
4/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
2/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
10.0%
4/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Vascular disorders
Orthostatic hypotension
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Skin and subcutaneous tissue disorders
Rash
4.8%
3/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Infections and infestations
Nasopharyngitis
3.2%
2/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
20.0%
4/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Injury, poisoning and procedural complications
Skin Abrasion
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
1.7%
1/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
11.1%
1/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Nervous system disorders
Taste Disorder
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.1%
3/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
2.5%
1/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.00%
0/63 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/59 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
5.0%
1/20 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/9 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.
0.00%
0/40 • Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Analysis was performed on safety-evaluable population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

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

Restriction type: OTHER