Trial Outcomes & Findings for A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT02611323)
NCT ID: NCT02611323
Last Updated: 2023-10-10
Results Overview
CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions. No new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
133 participants
Primary outcome timeframe
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21 days)
Results posted on
2023-10-10
Participant Flow
Participants took part in this study at 23 investigative centers in Australia, Italy, and the United States from 09 March 2016 up to 04 August 2022. The study consisted of two phases: a dose-escalation phase and a dose-expansion phase. All eligible participants in both dose-escalation and expansion phases received induction treatment, and post-induction treatment as indicated.
A total of 133 participants with relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) were enrolled in this study. Out of the 133, two participants did not receive any study treatment. Of the 131 treated participants, 74 participants with FL received Obinutuzumab (G) in combination with polatuzumab vedotin (P) and venetoclax (V) and 57 participants with DLBCL received rituximab (R) in combination with polatuzumab vedotin and venetoclax.
Participant milestones
| Measure |
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 milligrams (mg), orally, once daily (QD) on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, intravenous (IV) infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 milligrams per kilograms (mg/kg), IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
3
|
9
|
8
|
41
|
3
|
6
|
8
|
40
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
3
|
8
|
7
|
30
|
2
|
2
|
0
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
0
|
0
|
1
|
1
|
11
|
1
|
4
|
8
|
29
|
Reasons for withdrawal
| Measure |
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 milligrams (mg), orally, once daily (QD) on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, intravenous (IV) infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 milligrams per kilograms (mg/kg), IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
0
|
0
|
1
|
1
|
8
|
0
|
4
|
6
|
26
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
2
|
|
Overall Study
Found Another Malignancy After Starting Trial
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
FL Dose Escalation: 1.4P+400V+1000G
n=7 Participants
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+200V+1000G
n=3 Participants
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+400V+1000G
n=3 Participants
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+600V+1000G
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL: Dose Escalation: 1.8P+400V+375R
n=3 Participants
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=6 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
58.0 years
STANDARD_DEVIATION 11.9 • n=10 Participants
|
62.2 years
STANDARD_DEVIATION 11.3 • n=115 Participants
|
56.0 years
STANDARD_DEVIATION 16.5 • n=6 Participants
|
58.7 years
STANDARD_DEVIATION 17.4 • n=6 Participants
|
67.4 years
STANDARD_DEVIATION 15.2 • n=64 Participants
|
65.8 years
STANDARD_DEVIATION 9.6 • n=17 Participants
|
62.8 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
18 Participants
n=17 Participants
|
61 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
22 Participants
n=17 Participants
|
70 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
30 Participants
n=17 Participants
|
109 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
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=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=64 Participants
|
31 Participants
n=17 Participants
|
109 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21 days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at recommended phase 2 dose (RP2D) in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions. No new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CR at EOI Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans
|
100 percentage of participants
Interval 68.77 to 100.0
|
51.2 percentage of participants
Interval 37.44 to 64.86
|
25 percentage of participants
Interval 4.64 to 59.97
|
32.5 percentage of participants
Interval 20.41 to 46.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study start to 24 months after last dose of study drug (approximately 56 months)Population: Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
57.1 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
22.2 percentage of participants
|
75.0 percentage of participants
|
34.1 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study start to 3 months after last dose of study drug (approximately 21 months)Population: Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the NCI-CTCAE, v4.0. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
DLBCL Cohorts: Percentage of Participants With AEs and SAEs
SAEs
|
100 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
30.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DLBCL Cohorts: Percentage of Participants With AEs and SAEs
AEs
|
100 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
97.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phasePopulation: Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the dose-escalation cohorts cohorts were assessed in this outcome measure.
DLT=any one of the events that occurred in first treatment cycle \& per the investigator was related to study treatment. Any AE that lead to a delay of \> 14 days in start of next treatment cycle; Any Grade 3/4 non-hematologic AE with few exceptions; Any increase in hepatic transaminase \>3×baseline(BL) \& increase in direct bilirubin \>2×upper limit of normal (ULN), without any findings of cholestasis/jaundice/signs of hepatic dysfunction \& in absence of other contributory factors; Grade1 alanine transaminase (ALT)/aspartate transaminase (AST) elevation at BL as result of liver metastases, only a Grade ≥3 elevation, also ≥3×BL lasting \>7 days; Hematologic AE meeting protocol specified criteria. Events were graded per NCI CTCAE v4.0. Grade 1:Mild; asymptomatic/mild symptoms; Grade 2:Moderate;minimal,local/non-invasive intervention indicated; Grade 3:Severe/medically significant, but not immediately life-threatening; Grade 4:Life-threatening consequences/urgent intervention indicated.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=6 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phasePopulation: Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure.
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of polatuzumab vedotin when given in combination with fixed dose of obinutuzumab in participants with FL was determined.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=33 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
RP2D of Polatuzumab Vedotin
|
1.8 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phasePopulation: Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure.
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of venetoclax when given in combination with fixed dose of polatuzumab vedotin in participants with FL and DLBCL was determined.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=33 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=17 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
RP2D of Venetoclax
|
800 mg
|
800 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no evidence of FDG-avid disease in bone marrow. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans
|
100 percentage of participants
Interval 68.77 to 100.0
|
51.2 percentage of participants
Interval 37.44 to 64.86
|
25.0 percentage of participants
Interval 4.64 to 59.97
|
32.5 percentage of participants
Interval 20.41 to 46.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. Overall number analyzed is the number of participants with data available for analysis.
CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=34 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone
|
62.5 percentage of participants
Interval 28.92 to 88.89
|
36.6 percentage of participants
Interval 24.08 to 50.61
|
16.7 percentage of participants
Interval 0.85 to 58.18
|
26.5 percentage of participants
Interval 14.56 to 41.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
|
75.0 percentage of participants
Interval 40.03 to 95.36
|
29.3 percentage of participants
Interval 17.84 to 43.07
|
25.0 percentage of participants
Interval 4.64 to 59.97
|
22.5 percentage of participants
Interval 12.27 to 35.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes \& ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake\> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions \& no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (OR) at EOI, Determined by an IRC on the Basis of PET and CT Scans
|
100.0 percentage of participants
Interval 68.77 to 100.0
|
70.7 percentage of participants
Interval 56.93 to 82.16
|
25.0 percentage of participants
Interval 4.64 to 59.97
|
37.5 percentage of participants
Interval 24.73 to 51.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes \& ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake\> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions;no new lesions \& no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of PET and CT Scans
|
100.0 percentage of participants
Interval 68.77 to 100.0
|
75.6 percentage of participants
Interval 62.15 to 86.13
|
37.5 percentage of participants
Interval 11.11 to 71.08
|
42.5 percentage of participants
Interval 29.18 to 56.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With OR at EOI, Determined by an IRC on the Basis of CT Scans Alone
|
87.5 percentage of participants
Interval 52.93 to 99.36
|
82.9 percentage of participants
Interval 70.31 to 91.7
|
25.0 percentage of participants
Interval 4.64 to 59.97
|
37.5 percentage of participants
Interval 24.73 to 51.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
OR was defined as the percentage of participants with CR or PR, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
|
87.5 percentage of participants
Interval 52.93 to 99.36
|
85.4 percentage of participants
Interval 73.15 to 93.43
|
37.5 percentage of participants
Interval 11.11 to 71.08
|
45.0 percentage of participants
Interval 31.46 to 59.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months)Population: Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
BOR=CR or PR as assessed by investigator per CT per MLRC. Per MLRC, CR based on CT was defined as a complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. Percentages have been rounded off to the first decimal point.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response (BOR) of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone
|
100.0 percentage of participants
Interval 68.77 to 100.0
|
87.8 percentage of participants
Interval 76.05 to 95.07
|
50.0 percentage of participants
Interval 19.29 to 80.71
|
72.5 percentage of participants
Interval 58.61 to 83.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose & 0.5 hours post-dose on Day 1 Cycles 1, 2, 4, & 6; and pre-dose on Day 1 of Months 2, 8, 14, 20; study drug discontinuation, Day 120 &1 year post-last dose (up to approximately 40 months) (1 cycle = 21 days)Population: Pharmacokinetics (PK) evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=39 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Serum Obinutuzumab Concentration
Cycle 1 Day 1: Pre-dose
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were below lower limit of quantification (BLLQ).
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 1 Day 1: 0.5 hours Post Dose
|
310 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21.2
|
360 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 18.8
|
169 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 60.2
|
342 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 11.0
|
262 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 106.0
|
438 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 17.8
|
261 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 115.1
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 2 Day 1: Pre-dose
|
327 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 46.7
|
498 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20.6
|
288 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 43.2
|
395 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 17.0
|
435 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25.4
|
497 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20.3
|
422 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 29.0
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 2 Day 1: 0.5 hours Post Dose
|
637 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 32.0
|
822 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 17.0
|
512 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 56.1
|
685 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 17.8
|
800 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 19.1
|
975 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 19.3
|
834 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 30.3
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 4 Day 1: Pre-dose
|
284 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 50.9
|
496 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25.3
|
376 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 9.6
|
337 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 12.0
|
422 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20.3
|
454 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 37.2
|
397 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 40.5
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 4 Day 1: 0.5 hours Post Dose
|
534 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 62.9
|
842 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25.1
|
709 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20.1
|
732 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 13.4
|
819 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 18.6
|
925 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 26.9
|
770 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25.6
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 6 Day 1: Pre-dose
|
288 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 62.9
|
582 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 26.5
|
338 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 4.0
|
335 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 10.2
|
437 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24.5
|
420 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 44.5
|
428 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 51.9
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Cycle 6 Day 1: 0.5 hours Post Dose
|
582 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 26.8
|
887 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 19.6
|
490 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 65.2
|
659 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 14.3
|
857 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21.2
|
841 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 28.1
|
807 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Maintenance Month 2
|
117 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 471.2
|
294 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 53.3
|
205 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
192 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 11.7
|
273 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 63.4
|
327 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 57.6
|
291 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 60.8
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Maintenance Month 8
|
148 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 161.8
|
184 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
191 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
114 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 30.0
|
170 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 40.2
|
210 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 27.0
|
168 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 72.0
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Maintenance Month 14
|
189 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 112.9
|
226 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 28.9
|
197 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
138 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
133 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 23.5
|
190 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 17.9
|
168 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 41.3
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Maintenance Month 20
|
242 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
218 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 30.7
|
74.0 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
—
|
156 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 44.2
|
144 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 26.9
|
180 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 62.0
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Study Drug Discontinuation Visit
|
9.61 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 438943.9
|
134 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 1414.6
|
4.48 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 2973890.2
|
66.6 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 271.0
|
262 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 11.9
|
212 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 34.8
|
148 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 110.1
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
Day 120 Post Last Dose
|
39.9 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
—
|
1.72 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 1634893.3
|
0.660 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
41.2 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 89.5
|
94.6 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 85.6
|
44.1 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 274.2
|
—
|
—
|
—
|
—
|
|
Observed Serum Obinutuzumab Concentration
One Year Post Last Dose
|
0.0410 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20351.2
|
—
|
0.0585 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 372.7
|
0.00680 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.244 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 716.1
|
0.0820 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
4.89 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 9002.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1 and 6; pre-dose on Day 1 of Cycles 2 and 4; (1 cycle = 21 days)Population: PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=2 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=39 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Serum Rituximab Concentration
Cycle 1 Day 1: Pre-dose
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Serum Rituximab Concentration
Cycle 1 Day 1: 0.5 hours Post Dose
|
199 µg/mL
Geometric Coefficient of Variation 25.4
|
189 µg/mL
Geometric Coefficient of Variation 6.8
|
255 µg/mL
Geometric Coefficient of Variation 14.0
|
146 µg/mL
Geometric Coefficient of Variation 159.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Serum Rituximab Concentration
Cycle 2 Day 1: Pre-dose
|
49.3 µg/mL
Geometric Coefficient of Variation 17.2
|
38.9 µg/mL
Geometric Coefficient of Variation 61.7
|
71.0 µg/mL
Geometric Coefficient of Variation 42.1
|
50.1 µg/mL
Geometric Coefficient of Variation 30.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Serum Rituximab Concentration
Cycle 4 Day 1:Pre-dose
|
88.9 µg/mL
Geometric Coefficient of Variation 11.1
|
39.3 µg/mL
Geometric Coefficient of Variation 71.0
|
126 µg/mL
Geometric Coefficient of Variation 16.5
|
88.1 µg/mL
Geometric Coefficient of Variation 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Serum Rituximab Concentration
Cycle 6 Day 1: Pre-dose
|
120 µg/mL
Geometric Coefficient of Variation 8.8
|
20.9 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
151 µg/mL
Geometric Coefficient of Variation 32.4
|
117 µg/mL
Geometric Coefficient of Variation 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Serum Rituximab Concentration
Cycle 6 Day 1: 0.5 hours Post Dose
|
303 µg/mL
Geometric Coefficient of Variation 12.4
|
182 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
229 µg/mL
Geometric Coefficient of Variation 36.9
|
308 µg/mL
Geometric Coefficient of Variation 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2 and 4; study drug discontinuation visit; Day 120 and 1 year post-last dose (up to approximately 16 months) (1 cycle=21 days)Population: PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Total antibody is an analyte of polatuzumab vedotin.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=8 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=39 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Cycle 4 Day 1: Pre-dose
|
2.73 µg/mL
Geometric Coefficient of Variation 76.1
|
6.12 µg/mL
Geometric Coefficient of Variation 26.1
|
7.88 µg/mL
Geometric Coefficient of Variation 9.5
|
5.40 µg/mL
Geometric Coefficient of Variation 18.4
|
5.72 µg/mL
Geometric Coefficient of Variation 33.5
|
8.19 µg/mL
Geometric Coefficient of Variation 32.3
|
5.88 µg/mL
Geometric Coefficient of Variation 63.7
|
6.84 µg/mL
Geometric Coefficient of Variation 29.5
|
2.34 µg/mL
Geometric Coefficient of Variation 82.1
|
8.22 µg/mL
Geometric Coefficient of Variation 17.0
|
5.82 µg/mL
Geometric Coefficient of Variation 45.7
|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Cycle 1 Day 1: Pre-dose
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Cycle 2 Day 1: Pre-dose
|
0.798 µg/mL
Geometric Coefficient of Variation 404.2
|
3.14 µg/mL
Geometric Coefficient of Variation 29.4
|
0.677 µg/mL
Geometric Coefficient of Variation 6220.9
|
2.03 µg/mL
Geometric Coefficient of Variation 46.4
|
1.75 µg/mL
Geometric Coefficient of Variation 63.2
|
4.22 µg/mL
Geometric Coefficient of Variation 31.1
|
1.73 µg/mL
Geometric Coefficient of Variation 265.3
|
3.34 µg/mL
Geometric Coefficient of Variation 56.6
|
2.23 µg/mL
Geometric Coefficient of Variation 83.5
|
3.41 µg/mL
Geometric Coefficient of Variation 30.9
|
3.04 µg/mL
Geometric Coefficient of Variation 70.8
|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Study Drug Discontinuation Visit
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Values were less than reportable (LTR) for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
0.0534 µg/mL
Geometric Coefficient of Variation NA
Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.0900 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.110 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
2.43 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
4.71 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
1.38 µg/mL
Geometric Coefficient of Variation 203.0
|
1.03 µg/mL
Geometric Coefficient of Variation 471.1
|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Day 120 Post Last Dose
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0906 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0832 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.156 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.494 µg/mL
Geometric Coefficient of Variation 468.8
|
0.385 µg/mL
Geometric Coefficient of Variation 28.6
|
—
|
0.759 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
1.37 µg/mL
Geometric Coefficient of Variation 93.2
|
|
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
One Year Post Last Dose
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
—
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0294 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0250 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
—
|
0.0457 µg/mL
Geometric Coefficient of Variation NA
Since majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)Population: PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
acMMAE is an analyte of polatuzumab vedotin.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=39 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 1 Day 1: Pre-dose
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
The data is not evaluable as the samples were BLLQ.
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 1 Day 1: 0.5 hours Post Dose
|
131 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19054.2
|
530 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.2
|
451 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48.0
|
610 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 3.4
|
645 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.6
|
825 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.8
|
613 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38.2
|
722 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.3
|
628 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.1
|
683 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.2
|
481 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 226.7
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 1 Day 8: Post Dose
|
19.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 890.8
|
57.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19.3
|
9.87 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43972.4
|
49.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.6
|
58.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39.7
|
88.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.7
|
41.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 192.1
|
45.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.7
|
50.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42.6
|
77.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.3
|
57.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42.2
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 1 Day 15: Post Dose
|
6.67 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 421.2
|
22.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.1
|
4.56 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 5235.8
|
18.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.2
|
17.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.9
|
31.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15.3
|
14.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 176.9
|
26.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.8
|
19.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50.5
|
30.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21.5
|
22.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.6
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 2 Day 1: Pre-dose
|
3.69 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 296.8
|
12.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.9
|
3.25 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 2446.9
|
9.34 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44.7
|
8.27 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 62.6
|
16.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.2
|
7.71 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 209.4
|
14.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 66.9
|
8.94 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 100.6
|
14.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.2
|
13.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45.3
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 2 Day 1: 0.5 hours Post Dose
|
527 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.3
|
594 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.7
|
602 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.8
|
555 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 3.0
|
682 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.0
|
844 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19.7
|
688 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.7
|
749 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23.0
|
341 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 353.1
|
748 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 17.7
|
628 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.6
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 4 Day 1: Pre-dose
|
10.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.4
|
18.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.9
|
29.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 10.1
|
19.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 8.2
|
23.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.0
|
27.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37.0
|
21.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 53.3
|
24.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.8
|
8.16 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 245.5
|
30.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 12.3
|
22.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.8
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 4 Day 1: 0.5 hours Post Dose
|
491 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28.1
|
587 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 16.3
|
768 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.5
|
620 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 7.4
|
553 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 90.9
|
474 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 299.3
|
644 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 66.8
|
968 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.7
|
722 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 1.8
|
775 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15.2
|
680 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.9
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
Cycle 6 Day 1: Pre-dose
|
13.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58.5
|
4.62 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 5273.1
|
23.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42.5
|
20.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 3.7
|
28.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.2
|
27.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.9
|
25.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.9
|
24.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.4
|
3.73 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
31.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46.0
|
24.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54.4
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)Population: PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
MMAE is an analyte of polatuzumab vedotin.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=38 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 1 Day 1: Pre-dose
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 1 Day 1: 0.5 hours Post Dose
|
0.313 ng/mL
Geometric Coefficient of Variation 725.2
|
0.236 ng/mL
Geometric Coefficient of Variation 31.1
|
1.04 ng/mL
Geometric Coefficient of Variation 575.7
|
0.417 ng/mL
Geometric Coefficient of Variation 60.3
|
0.507 ng/mL
Geometric Coefficient of Variation 112.0
|
NA ng/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ
|
0.441 ng/mL
Geometric Coefficient of Variation 208.3
|
0.249 ng/mL
Geometric Coefficient of Variation 8.7
|
0.390 ng/mL
Geometric Coefficient of Variation 89.0
|
0.262 ng/mL
Geometric Coefficient of Variation 61.9
|
0.263 ng/mL
Geometric Coefficient of Variation 90.8
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 1 Day 8: Post Dose
|
1.14 ng/mL
Geometric Coefficient of Variation 34.8
|
57.5 ng/mL
Geometric Coefficient of Variation 1.46
|
1.57 ng/mL
Geometric Coefficient of Variation 63.6
|
1.06 ng/mL
Geometric Coefficient of Variation 43.6
|
1.66 ng/mL
Geometric Coefficient of Variation 69.9
|
0.323 ng/mL
Geometric Coefficient of Variation 79.3
|
1.81 ng/mL
Geometric Coefficient of Variation 65.3
|
2.34 ng/mL
Geometric Coefficient of Variation 54.7
|
2.77 ng/mL
Geometric Coefficient of Variation 63.1
|
2.51 ng/mL
Geometric Coefficient of Variation 96.3
|
2.51 ng/mL
Geometric Coefficient of Variation 65.1
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 1 Day 15: Post Dose
|
0.225 ng/mL
Geometric Coefficient of Variation 87.4
|
0.310 ng/mL
Geometric Coefficient of Variation 60.2
|
0.213 ng/mL
Geometric Coefficient of Variation 174.3
|
0.341 ng/mL
Geometric Coefficient of Variation 55.9
|
0.461 ng/mL
Geometric Coefficient of Variation 76.6
|
2.26 ng/mL
Geometric Coefficient of Variation 76.3
|
0.444 ng/mL
Geometric Coefficient of Variation 99.8
|
0.675 ng/mL
Geometric Coefficient of Variation 144.7
|
0.927 ng/mL
Geometric Coefficient of Variation 89.8
|
0.778 ng/mL
Geometric Coefficient of Variation 77.9
|
0.723 ng/mL
Geometric Coefficient of Variation 63.3
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 2 Day 1: Pre-dose
|
0.0575 ng/mL
Geometric Coefficient of Variation 117.0
|
0.103 ng/mL
Geometric Coefficient of Variation 47.1
|
0.0565 ng/mL
Geometric Coefficient of Variation 132.5
|
0.0982 ng/mL
Geometric Coefficient of Variation 75.3
|
0.0866 ng/mL
Geometric Coefficient of Variation 141.8
|
0.688 ng/mL
Geometric Coefficient of Variation 73.8
|
0.113 ng/mL
Geometric Coefficient of Variation 136.1
|
0.221 ng/mL
Geometric Coefficient of Variation 199.1
|
0.311 ng/mL
Geometric Coefficient of Variation 76.4
|
0.266 ng/mL
Geometric Coefficient of Variation 161.7
|
0.227 ng/mL
Geometric Coefficient of Variation 66.1
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 2 Day 1: 0.5 hours Post Dose
|
0.152 ng/mL
Geometric Coefficient of Variation 46.2
|
0.184 ng/mL
Geometric Coefficient of Variation 29.0
|
0.399 ng/mL
Geometric Coefficient of Variation 104.7
|
0.175 ng/mL
Geometric Coefficient of Variation 57.0
|
0.231 ng/mL
Geometric Coefficient of Variation 76.5
|
0.150 ng/mL
Geometric Coefficient of Variation 41.9
|
0.257 ng/mL
Geometric Coefficient of Variation 63.8
|
0.343 ng/mL
Geometric Coefficient of Variation 122.0
|
0.564 ng/mL
Geometric Coefficient of Variation 76.4
|
0.407 ng/mL
Geometric Coefficient of Variation 116.2
|
0.322 ng/mL
Geometric Coefficient of Variation 55.9
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 4 Day 1: Pre-dose
|
0.131 ng/mL
Geometric Coefficient of Variation 58.2
|
0.106 ng/mL
Geometric Coefficient of Variation 48.3
|
0.180 ng/mL
Geometric Coefficient of Variation 62.4
|
0.172 ng/mL
Geometric Coefficient of Variation 46.8
|
0.155 ng/mL
Geometric Coefficient of Variation 46.5
|
0.263 ng/mL
Geometric Coefficient of Variation 46.5
|
0.167 ng/mL
Geometric Coefficient of Variation 81.0
|
0.238 ng/mL
Geometric Coefficient of Variation 75.5
|
0.459 ng/mL
Geometric Coefficient of Variation 103.4
|
0.295 ng/mL
Geometric Coefficient of Variation 90.5
|
0.220 ng/mL
Geometric Coefficient of Variation 72.7
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 4 Day 1: 0.5 hours Post Dose
|
0.235 ng/mL
Geometric Coefficient of Variation 84.2
|
0.163 ng/mL
Geometric Coefficient of Variation 50.6
|
0.255 ng/mL
Geometric Coefficient of Variation 48.6
|
0.270 ng/mL
Geometric Coefficient of Variation 31.6
|
0.209 ng/mL
Geometric Coefficient of Variation 42.0
|
0.206 ng/mL
Geometric Coefficient of Variation 36.2
|
0.260 ng/mL
Geometric Coefficient of Variation 56.2
|
0.331 ng/mL
Geometric Coefficient of Variation 77.4
|
0.565 ng/mL
Geometric Coefficient of Variation 107.5
|
0.364 ng/mL
Geometric Coefficient of Variation 65.6
|
0.311 ng/mL
Geometric Coefficient of Variation 57.7
|
|
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Cycle 6 Day 1: Pre-dose
|
0.107 ng/mL
Geometric Coefficient of Variation 73.4
|
0.120 ng/mL
Geometric Coefficient of Variation 62.3
|
0.0715 ng/mL
Geometric Coefficient of Variation NA
Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
0.239 ng/mL
Geometric Coefficient of Variation 17.2
|
0.189 ng/mL
Geometric Coefficient of Variation 37.2
|
0.289 ng/mL
Geometric Coefficient of Variation 55.2
|
0.162 ng/mL
Geometric Coefficient of Variation 94.9
|
0.197 ng/mL
Geometric Coefficient of Variation 275.2
|
0.795 ng/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.334 ng/mL
Geometric Coefficient of Variation 62.1
|
0.211 ng/mL
Geometric Coefficient of Variation 93.8
|
SECONDARY outcome
Timeframe: Pre-dose and 4 hours post-dose on Day 1 Cycle 1, pre-dose & 2, 4, 6, & 8 hours post-dose on Day 1 Cycle 2, pre-dose & 4hours post-dose on Day 1 Cycle 4 & pre-dose on Day 1 Cycle 6; (1 cycle = 21 days)Population: PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Plasma Venetoclax Concentration
Cycle 2 Day 1: Pre-dose
|
0.336 µg/mL
Geometric Coefficient of Variation 99.3
|
0.347 µg/mL
Geometric Coefficient of Variation 144.3
|
0.453 µg/mL
Geometric Coefficient of Variation 71.9
|
0.943 µg/mL
Geometric Coefficient of Variation 28.5
|
0.298 µg/mL
Geometric Coefficient of Variation 2853.1
|
0.282 µg/mL
Geometric Coefficient of Variation 498.3
|
0.555 µg/mL
Geometric Coefficient of Variation 1134.4
|
0.529 µg/mL
Geometric Coefficient of Variation 135.6
|
0.952 µg/mL
Geometric Coefficient of Variation 139.7
|
0.852 µg/mL
Geometric Coefficient of Variation 1812.3
|
0.329 µg/mL
Geometric Coefficient of Variation 1047.7
|
|
Observed Plasma Venetoclax Concentration
Cycle 4 Day 1: Post Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.04 µg/mL
Geometric Coefficient of Variation 8.4
|
|
Observed Plasma Venetoclax Concentration
Cycle 6 Day 1: Pre-dose
|
0.252 µg/mL
Geometric Coefficient of Variation 95.0
|
0.277 µg/mL
Geometric Coefficient of Variation 178.7
|
0.0177 µg/mL
Geometric Coefficient of Variation NA
Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
|
1.24 µg/mL
Geometric Coefficient of Variation 56.1
|
0.595 µg/mL
Geometric Coefficient of Variation 95.4
|
0.0266 µg/mL
Geometric Coefficient of Variation 26843.8
|
0.509 µg/mL
Geometric Coefficient of Variation 496.6
|
0.175 µg/mL
Geometric Coefficient of Variation 187.9
|
1.90 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.0772 µg/mL
Geometric Coefficient of Variation 101668.3
|
0.365 µg/mL
Geometric Coefficient of Variation 780.9
|
|
Observed Plasma Venetoclax Concentration
Cycle 1 Day 1: Pre-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA µg/mL
Geometric Coefficient of Variation NA
The data was not evaluable as the samples were BLLQ.
|
|
Observed Plasma Venetoclax Concentration
Cycle 1 Day 1: Post Dose
|
0.624 µg/mL
Geometric Coefficient of Variation 94.6
|
0.247 µg/mL
Geometric Coefficient of Variation 162.1
|
0.108 µg/mL
Geometric Coefficient of Variation 53.3
|
0.244 µg/mL
Geometric Coefficient of Variation 149.1
|
0.796 µg/mL
Geometric Coefficient of Variation 86.5
|
0.811 µg/mL
Geometric Coefficient of Variation 310.3
|
0.964 µg/mL
Geometric Coefficient of Variation 69.2
|
0.503 µg/mL
Geometric Coefficient of Variation 47.9
|
0.915 µg/mL
Geometric Coefficient of Variation 47.4
|
1.21 µg/mL
Geometric Coefficient of Variation 103.4
|
0.841 µg/mL
Geometric Coefficient of Variation 94.8
|
|
Observed Plasma Venetoclax Concentration
Cycle 2 Day 1: 2 hours Post Dose
|
0.532 µg/mL
Geometric Coefficient of Variation 119.2
|
0.306 µg/mL
Geometric Coefficient of Variation 107.3
|
0.351 µg/mL
Geometric Coefficient of Variation 129.3
|
0.822 µg/mL
Geometric Coefficient of Variation 54.8
|
0.769 µg/mL
Geometric Coefficient of Variation 131.0
|
0.921 µg/mL
Geometric Coefficient of Variation 74.0
|
2.69 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.632 µg/mL
Geometric Coefficient of Variation 90.1
|
1.08 µg/mL
Geometric Coefficient of Variation 82.0
|
1.01 µg/mL
Geometric Coefficient of Variation 464.7
|
NA µg/mL
Geometric Coefficient of Variation 5.13
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
|
Observed Plasma Venetoclax Concentration
Cycle 2 Day 1: 4 hours Post Dose
|
1.12 µg/mL
Geometric Coefficient of Variation 102.2
|
0.572 µg/mL
Geometric Coefficient of Variation 49.1
|
0.548 µg/mL
Geometric Coefficient of Variation 51.0
|
1.31 µg/mL
Geometric Coefficient of Variation 22.5
|
1.65 µg/mL
Geometric Coefficient of Variation 69.4
|
2.04 µg/mL
Geometric Coefficient of Variation 39.2
|
1.99 µg/mL
Geometric Coefficient of Variation 59.0
|
0.830 µg/mL
Geometric Coefficient of Variation 75.3
|
1.49 µg/mL
Geometric Coefficient of Variation 43.1
|
2.03 µg/mL
Geometric Coefficient of Variation 131.4
|
1.50 µg/mL
Geometric Coefficient of Variation 74.5
|
|
Observed Plasma Venetoclax Concentration
Cycle 2 Day 1: 6 hours Post Dose
|
1.38 µg/mL
Geometric Coefficient of Variation 83.4
|
0.933 µg/mL
Geometric Coefficient of Variation 72.1
|
1.21 µg/mL
Geometric Coefficient of Variation 24.8
|
1.99 µg/mL
Geometric Coefficient of Variation 5.7
|
2.15 µg/mL
Geometric Coefficient of Variation 51.9
|
2.55 µg/mL
Geometric Coefficient of Variation 28.0
|
4.82 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.870 µg/mL
Geometric Coefficient of Variation 98.1
|
1.96 µg/mL
Geometric Coefficient of Variation 57.5
|
2.74 µg/mL
Geometric Coefficient of Variation 117.9
|
5.95 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
|
Observed Plasma Venetoclax Concentration
Cycle 2 Day 1: 8 hours Post Dose
|
1.40 µg/mL
Geometric Coefficient of Variation 74.9
|
0.803 µg/mL
Geometric Coefficient of Variation 76.7
|
1.45 µg/mL
Geometric Coefficient of Variation 32.3
|
2.24 µg/mL
Geometric Coefficient of Variation 18.4
|
2.46 µg/mL
Geometric Coefficient of Variation 59.8
|
2.53 µg/mL
Geometric Coefficient of Variation 32.7
|
3.02 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
0.886 µg/mL
Geometric Coefficient of Variation 87.6
|
1.88 µg/mL
Geometric Coefficient of Variation 70.8
|
2.85 µg/mL
Geometric Coefficient of Variation 94.7
|
6.66 µg/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
|
|
Observed Plasma Venetoclax Concentration
Cycle 4 Day 1: Pre-dose
|
0.259 µg/mL
Geometric Coefficient of Variation 157.2
|
0.0344 µg/mL
Geometric Coefficient of Variation 15072.4
|
0.302 µg/mL
Geometric Coefficient of Variation 1.2
|
1.12 µg/mL
Geometric Coefficient of Variation 40.2
|
0.551 µg/mL
Geometric Coefficient of Variation 98.4
|
0.304 µg/mL
Geometric Coefficient of Variation 1059.7
|
0.561 µg/mL
Geometric Coefficient of Variation 401.2
|
0.0581 µg/mL
Geometric Coefficient of Variation 1105.7
|
0.933 µg/mL
Geometric Coefficient of Variation 74.2
|
0.826 µg/mL
Geometric Coefficient of Variation 311.3
|
0.337 µg/mL
Geometric Coefficient of Variation 1043.6
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2 years after last dose (up to approximately 56 months)Population: The immunogenicity population included participants with at least one predose and one postdose HAHA or ATA assessment, with participants grouped according to histology. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The number of participants with positive results for HAHAs, also called anti-drug antibodies (ADAs) against obinutuzumab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = 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 (t.u.) greater than the baseline titer result.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=39 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Baseline prevalence of ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Post baseline incidence of ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 1 year post last dose (up to approximately 16 months)Population: Immunogenicity population included participants with at least one predose and one postdose HAHA or ATA assessment, with participants grouped according to histology. Number analyzed is the number of participants with data available for analysis.
The number of participants with positive results for ATAs, also called ADAs against polatuzumab vedotin at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = 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 t.u. greater than the baseline titer result.
Outcome measures
| Measure |
FL Dose Escalation: 1.8P+800V+1000G
n=7 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=3 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=3 Participants
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=6 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 Participants
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Polatuzumab Vedotin
Baseline prevalence of ADAs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Polatuzumab Vedotin
Post baseline incidence of ADAs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
FL Dose Escalation: 1.4P+400V+1000G
Serious events: 4 serious events
Other events: 7 other events
Deaths: 3 deaths
FL Dose Escalation: 1.4P+200V+1000G
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
FL Dose Escalation: 1.8P+400V+1000G
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
FL Dose Escalation: 1.4P+600V+1000G
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FL Dose Escalation: 1.8P+600V+1000G
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
FL Dose Escalation: 1.8P+800V+1000G
Serious events: 6 serious events
Other events: 8 other events
Deaths: 1 deaths
FL: Dose Expansion: 1.8P+800V+1000G
Serious events: 14 serious events
Other events: 41 other events
Deaths: 8 deaths
DLBCL: Dose Escalation: 1.8P+400V+375R
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
DLBCL Dose Escalation: 1.8P+600V+375R
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
DLBCL Dose Escalation: 1.8P+800V+375R
Serious events: 2 serious events
Other events: 7 other events
Deaths: 6 deaths
DLBCL Dose Expansion: 1.8P+800V+375R
Serious events: 12 serious events
Other events: 38 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
FL Dose Escalation: 1.4P+400V+1000G
n=7 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+200V+1000G
n=3 participants at risk
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+400V+1000G
n=3 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+600V+1000G
n=3 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL: Dose Escalation: 1.8P+400V+375R
n=3 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=6 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
RETINAL TEAR
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
PYREXIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PNEUMONIA
|
28.6%
2/7 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Product Issues
DEVICE LEAKAGE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.3%
1/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
Other adverse events
| Measure |
FL Dose Escalation: 1.4P+400V+1000G
n=7 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+200V+1000G
n=3 participants at risk
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+400V+1000G
n=3 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.4P+600V+1000G
n=3 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+600V+1000G
n=9 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL Dose Escalation: 1.8P+800V+1000G
n=8 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
FL: Dose Expansion: 1.8P+800V+1000G
n=41 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
|
DLBCL: Dose Escalation: 1.8P+400V+375R
n=3 participants at risk
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+600V+375R
n=6 participants at risk
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Escalation: 1.8P+800V+375R
n=8 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
DLBCL Dose Expansion: 1.8P+800V+375R
n=40 participants at risk
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m\^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m\^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
17.1%
7/41 • Number of events 13 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
5/40 • Number of events 9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
HYPERGAMMAGLOBULINAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
44.4%
4/9 • Number of events 17 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
62.5%
5/8 • Number of events 23 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
41.5%
17/41 • Number of events 46 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
62.5%
5/8 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
20/40 • Number of events 64 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
42.9%
3/7 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
29.3%
12/41 • Number of events 37 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
15.0%
6/40 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Ear and labyrinth disorders
OTORRHOEA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Ear and labyrinth disorders
VERTIGO
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
CATARACT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
SCLERAL HYPERAEMIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
CONSTIPATION
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
24.4%
10/41 • Number of events 14 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
15.0%
6/40 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DIARRHOEA
|
42.9%
3/7 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
100.0%
3/3 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
55.6%
5/9 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
75.0%
6/8 • Number of events 14 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
48.8%
20/41 • Number of events 42 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
100.0%
3/3 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
62.5%
5/8 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
40.0%
16/40 • Number of events 20 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
14.6%
6/41 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
FAECES SOFT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
MUCOUS STOOLS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
NAUSEA
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
56.1%
23/41 • Number of events 35 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
100.0%
3/3 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
3/6 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
35.0%
14/40 • Number of events 15 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ORAL DISCHARGE
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Gastrointestinal disorders
VOMITING
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
26.8%
11/41 • Number of events 17 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
3/6 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 11 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
20.0%
8/40 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
ASTHENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
CHEST PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
CHILLS
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
EARLY SATIETY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
FATIGUE
|
71.4%
5/7 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
31.7%
13/41 • Number of events 14 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
10/40 • Number of events 10 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
INJECTION SITE EXTRAVASATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
MALAISE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
OEDEMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
OEDEMA MUCOSAL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
General disorders
PYREXIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
15.0%
6/40 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
BACTERIAL DISEASE CARRIER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
BRONCHITIS
|
14.3%
1/7 • Number of events 12 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CHRONIC SINUSITIS
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
GASTROINTESTINAL VIRAL INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
HERPES ZOSTER
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
OTITIS MEDIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
57.1%
4/7 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
26.8%
11/41 • Number of events 18 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
44.4%
4/9 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
31.7%
13/41 • Number of events 14 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
SKIN WOUND
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS SITE PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD CALCIUM DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD CALCIUM INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD CREATININE INCREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD FIBRINOGEN DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD IMMUNOGLOBULIN G DECREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
INFLUENZA A VIRUS TEST POSITIVE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
OCCULT BLOOD POSITIVE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
PROTEIN TOTAL DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
PROTEIN URINE PRESENT
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
RED BLOOD CELLS URINE POSITIVE
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
URINARY CASTS PRESENT
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Investigations
WEIGHT DECREASED
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
17.1%
7/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
2/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
3/6 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
15.0%
6/40 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
GOUT
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OCULAR SURFACE SQUAMOUS NEOPLASIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
4/6 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
3/6 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
17.1%
7/41 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
19.5%
8/41 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Musculoskeletal and connective tissue disorders
PLANTAR FASCIITIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Reproductive system and breast disorders
ANISOMASTIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OCULAR MELANOMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
HEADACHE
|
28.6%
2/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
19.5%
8/41 • Number of events 15 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
37.5%
3/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
26.8%
11/41 • Number of events 11 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
5/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
PARAESTHESIA
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
14.6%
6/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
RESTING TREMOR
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
TASTE DISORDER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
DEPRESSION
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
INSOMNIA
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
14.6%
6/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
DYSURIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Renal and urinary disorders
URINE ABNORMALITY
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Reproductive system and breast disorders
BREAST CYST
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Reproductive system and breast disorders
ENDOMETRIAL THICKENING
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Reproductive system and breast disorders
PROSTATIC DISORDER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
42.9%
3/7 • Number of events 8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
3/9 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
50.0%
4/8 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
26.8%
11/41 • Number of events 14 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
66.7%
2/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.5%
9/40 • Number of events 11 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
14.3%
1/7 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
14.6%
6/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.2%
5/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 4 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
10.0%
4/40 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
14.3%
1/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
28.6%
2/7 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
14.3%
1/7 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
MILIARIA
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
4.9%
2/41 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
16.7%
1/6 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.5%
3/40 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
9.8%
4/41 • Number of events 7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
5.0%
2/40 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERTROPHY
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Skin and subcutaneous tissue disorders
SOLAR LENTIGO
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 5 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
22.2%
2/9 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
25.0%
2/8 • Number of events 2 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
11.1%
1/9 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
7.3%
3/41 • Number of events 3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
12.5%
1/8 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.5%
1/40 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
POOR VENOUS ACCESS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/41 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
|
Vascular disorders
SUPERFICIAL VEIN THROMBOSIS
|
0.00%
0/7 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
33.3%
1/3 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/9 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
2.4%
1/41 • Number of events 1 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/3 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/6 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/8 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
0.00%
0/40 • FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
|
Additional Information
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