A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With... | NCT01691898 | Trialant
NCT01691898
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Feb 21, 2020Actual
Enrollment
231Actual
Phase
Phase 1Phase 2
Conditions
Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Interventions
Obinutuzumab
Pinatuzumab Vedotin
Polatuzumab Vedotin
Rituximab
Countries
United States
Canada
France
Germany
Italy
Netherlands
Protocol Section
Identification Module
NCT ID
NCT01691898
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO27834
Secondary IDs
ID
Type
Description
Link
2011-004377-84
EudraCT Number
Brief Title
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Official Title
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Acronym
ROMULUS
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 27, 2012Actual
Primary Completion Date
Mar 8, 2017Actual
Completion Date
Feb 7, 2019Actual
First Submitted Date
Sep 16, 2012
First Submission Date that Met QC Criteria
Sep 20, 2012
First Posted Date
Sep 25, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 6, 2018
Results First Submitted that Met QC Criteria
Apr 18, 2018
Results First Posted Date
Apr 19, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 20, 2020
Last Update Posted Date
Feb 21, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).
Detailed Description
Not provided
Conditions Module
Conditions
Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
231Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Experimental
For the first 2 cycles, RTX 375 milligrams per square meter (mg/m^2) will be given by intravenous (IV) infusion on Day 1 and pinatuzumab vedotin 2.4 milligrams per kilogram (mg/kg) will be administered by IV infusion on Day 2 to Arm A participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and pinatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop disease progression (PD) will be further treated with RTX 375 mg/m^2 followed by polatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
Drug: Pinatuzumab Vedotin
Drug: Polatuzumab Vedotin
Drug: Rituximab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Experimental
For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 2.4 mg/kg will be administered by IV infusion on Day 2 to Arm B participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop PD would be further treated with RTX 375 mg/m^2 followed by pinatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
Drug: Pinatuzumab Vedotin
Drug: Polatuzumab Vedotin
Drug: Rituximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Obinutuzumab
Drug
Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.
Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)
Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)
Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Life expectancy of at least 12 weeks
History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL
Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
Have a clinical indication for treatment as determined by the investigator
Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by CT scan or Magnetic Resonance Imaging [MRI])
Exclusion Criteria:
Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to Grade less than equal to (</=) 2 prior study start
Completion of autologous stem cell transplant (SCT) within 100 days prior study start
Prior allogeneic SCT
Eligibility for autologous SCT (participants with r/r DLBCL)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
History of other malignancy that could affect compliance with the protocol or interpretation of results
Current or past history of central nervous system lymphoma
Current Grade >1 peripheral neuropathy
Vaccination with a live vaccine within 28 days prior to treatment
Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.
A total of 289 participants were screened, out of which, 231 participants were enrolled into the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 3, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort C (FL): RTX + Polatuzumab
Experimental
For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort C participants (with r/r FL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, PD, or withdrawal from study.
Drug: Polatuzumab Vedotin
Drug: Rituximab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Experimental
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort E participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Experimental
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort G participants (with r/r FL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort G participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Experimental
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort H participants (with r/r DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort H participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
GA101, Gazyva, Gazyvaro
Pinatuzumab Vedotin
Drug
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
DCDT2980S
Polatuzumab Vedotin
Drug
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort C (FL): RTX + Polatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
DCDS4501A
Rituximab
Drug
RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle.
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort C (FL): RTX + Polatuzumab
MabThera/Rituxan
Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [](streamdown:incomplete-link)
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Baseline, post-baseline (up to approximately 5.5 years)
Number of Participants With ADA to Polatuzumab Vedotin
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Baseline, post-baseline (up to approximately 5.5 years)
Number of Participants With ADA to Obinutuzumab
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Baseline, post-baseline (up to approximately 5.5 years)
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
Percentage of participants who died due to any cause was reported.
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)
OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (\
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to \
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
CL for rituximab was estimated from serum concentration data using non-compartmental analysis.
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis.
Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days).
Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)
Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
Vss for rituximab was estimated from serum concentration data using non-compartmental analysis.
Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)
AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Percentage of participants who died due to any cause was reported.
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)
Stanford
California
94305-5820
United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver
Colorado
80218
United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C.
District of Columbia
20007
United States
Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
Fort Myers
Florida
33905
United States
Florida Cancer Specialists; Sarasota
Sarasota
Florida
34232
United States
Univ of Michigan Med School; Hematology Oncology
Ann Arbor
Michigan
48109
United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas
Nevada
89169
United States
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown
New Jersey
07960
United States
Regional Cancer Care Associates LLC - Morristown
Morristown
New Jersey
07962
United States
Roswell Park Cancer Inst.
Buffalo
New York
14263
United States
New York University Cancer Cen
New York
New York
10016
United States
Oncology Hematology Care Inc
Cincinnati
Ohio
45242
United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene
Oregon
97401-8122
United States
Oregon Health Sciences Uni
Portland
Oregon
97239
United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville
Tennessee
37203
United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas
Texas
75246
United States
Cancer Care Centers of South Texas
San Antonio
Texas
78217
United States
Texas Transplant Inst.
San Antonio
Texas
78229
United States
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler
Texas
75702
United States
Fairfax N Virginia Hem/Onc PC
Fairfax
Virginia
22031
United States
Oncology & Hematolgy Associates of SW Va Inc. - Roanoke
Roanoke
Virginia
24014
United States
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109
United States
Northwest Cancer Specialists - Vancouver
Vancouver
Washington
98684
United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima
Washington
98902
United States
Univ of Wisconsin-Madison
Madison
Wisconsin
53705
United States
Cross Cancer Institute
Edmonton
Alberta
T6G 1Z2
Canada
British Columbia Cancer Agency
Vancouver
British Columbia
V5Z 1H6
Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal
Quebec
H3T 1E2
Canada
Hopital Claude Huriez - CHU Lille
Lille
59037
France
CHU Montpellier - Saint ELOI
Montpellier
34295
France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna
Emilia-Romagna
40138
Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan
Lombardy
20133
Italy
Azienda Ospedale San Giovanni
Turin
Piedmont
10126
Italy
Academisch Medisch Centrum; Hematologie
Amsterdam
1105 AZ
Netherlands
Derived
Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.
Morschhauser F, Flinn IW, Advani R, Sehn LH, Diefenbach C, Kolibaba K, Press OW, Salles G, Tilly H, Chen AI, Assouline S, Cheson BD, Dreyling M, Hagenbeek A, Zinzani PL, Jones S, Cheng J, Lu D, Penuel E, Hirata J, Wenger M, Chu YW, Sharman J. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265. doi: 10.1016/S2352-3026(19)30026-2. Epub 2019 Mar 29.
FG001
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
FG002
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
FG003
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
FG004
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
FG005
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
FG00063 subjects
FG00159 subjects
FG00220 subjects
FG0039 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG00016 subjects
FG00115 subjects
FG00211 subjects
FG0034 subjects
FG00426 subjects
FG0055 subjects
NOT COMPLETED
FG00047 subjects
FG00144 subjects
FG0029 subjects
FG0035 subjects
FG00414 subjects
FG00535 subjects
Type
Comment
Reasons
Death
FG00034 subjects
FG00132 subjects
FG0026 subjects
FG0033 subjects
FG0048 subjects
FG00531 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Progression of Disease
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG0018 subjects
FG0022 subjects
FG0031 subjects
FG004
Non-Compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Analysis was performed on safety-evaluable population, which included all participants who received at least 1 dose of all study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
BG001
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
BG002
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
BG003
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
BG004
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
BG005
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00063
BG00159
BG00220
BG0039
BG00440
BG00540
BG006231
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00124
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00042
OG00121
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG00059.5(45.67 to 72.32)
OG00161.9(41.72 to 79.43)
OG00253.8(39.58 to 67.65)
OG003
Primary
Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response.
Posted
Median
Full Range
months
First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Primary
Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H
Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [](streamdown:incomplete-link)
Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
Posted
Number
participants
Baseline, post-baseline (up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Number of Participants With ADA to Polatuzumab Vedotin
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
Posted
Number
participants
Baseline, post-baseline (up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Number of Participants With ADA to Obinutuzumab
Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
Posted
Number
participants
Baseline, post-baseline (up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
Posted
Number
percentage of participants
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
Posted
Median
95% Confidence Interval
months
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
Percentage of participants who died due to any cause was reported.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
Posted
Number
percentage of participants
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)
OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
Posted
Median
95% Confidence Interval
months
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Secondary
Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \
Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (\
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to \
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable pharmacokinetic (PK) concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*micrograms (mcg)/milliliter (mL)
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Secondary
Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Secondary
Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
CL for rituximab was estimated from serum concentration data using non-compartmental analysis.
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mL/day/meter-square (m^2)
Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Secondary
Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis.
Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days).
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
days
Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
Vss for rituximab was estimated from serum concentration data using non-compartmental analysis.
Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mL/m^2
Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*nanogram (ng)/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Secondary
Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Secondary
Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Secondary
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Secondary
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Secondary
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG001
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Secondary
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Secondary
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Secondary
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
Secondary
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Secondary
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Secondary
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
Secondary
AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Secondary
AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Secondary
AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.
Posted
Mean
Standard Deviation
day*ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Secondary
Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.
Analysis was performed on all participants who received obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Percentage of participants who died due to any cause was reported.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
Posted
Number
percentage of participants
Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
Posted
Median
95% Confidence Interval
months
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Secondary
Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
Posted
Number
percentage of participants
Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)
ID
Title
Description
OG000
Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Time Frame
Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
Description
Analysis was performed on safety-evaluable population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
35
63
27
63
63
63
EG001
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
33
59
21
59
58
59
EG002
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
6
20
8
20
20
20
EG003
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
4
9
3
9
9
9
EG004
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
8
40
9
40
37
40
EG005
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
32
40
18
40
38
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coagulopathy
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG0030 affected9 at risk
EG0040 affected40 at risk
EG0050 affected40 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0012 affected59 at risk
EG0022 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Fistula of small intestine
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Hernial eventration
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Axillary pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Chest discomfort
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
General physical health deterioration
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Malaise
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Sudden death
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Device related infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Febrile infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Lung infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Septic shock
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Viral diarrhoea
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Ganglioneuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Liver Disorder
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0009 affected63 at risk
EG00110 affected59 at risk
EG0021 affected20 at risk
EG0032 affected9 at risk
EG0044 affected40 at risk
EG0054 affected40 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG00019 affected63 at risk
EG00115 affected59 at risk
EG0028 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0013 affected59 at risk
EG0020 affected20 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Dry eye
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Eye pain
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Vision blurred
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0012 affected59 at risk
EG0022 affected20 at risk
EG003
Visual impairment
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0013 affected59 at risk
EG0021 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00011 affected63 at risk
EG00111 affected59 at risk
EG0022 affected20 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0014 affected59 at risk
EG0022 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00018 affected63 at risk
EG00114 affected59 at risk
EG0025 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00028 affected63 at risk
EG00125 affected59 at risk
EG0025 affected20 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0015 affected59 at risk
EG0021 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0018 affected59 at risk
EG0023 affected20 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00020 affected63 at risk
EG00125 affected59 at risk
EG00211 affected20 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0012 affected59 at risk
EG0022 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00011 affected63 at risk
EG00113 affected59 at risk
EG0023 affected20 at risk
EG003
Asthenia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG00011 affected63 at risk
EG00116 affected59 at risk
EG0020 affected20 at risk
EG003
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0016 affected59 at risk
EG0022 affected20 at risk
EG003
Chills
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0014 affected59 at risk
EG0023 affected20 at risk
EG003
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG00032 affected63 at risk
EG00134 affected59 at risk
EG00213 affected20 at risk
EG003
Feeling hot
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Gait disturbance
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0013 affected59 at risk
EG0021 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0018 affected59 at risk
EG0020 affected20 at risk
EG003
Malaise
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0021 affected20 at risk
EG003
Nodule
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0018 affected59 at risk
EG0023 affected20 at risk
EG003
Pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0011 affected59 at risk
EG0023 affected20 at risk
EG003
Peripheral swelling
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG00015 affected63 at risk
EG0019 affected59 at risk
EG0025 affected20 at risk
EG003
Unevaluable event
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Candida infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Ear infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0012 affected59 at risk
EG0021 affected20 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Rash pustular
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0022 affected20 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0012 affected59 at risk
EG0023 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0011 affected59 at risk
EG0022 affected20 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0012 affected59 at risk
EG0020 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Blood potassium decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Lipase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0014 affected59 at risk
EG0020 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Protein total decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0017 affected59 at risk
EG0023 affected20 at risk
EG003
Weight increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0014 affected59 at risk
EG0020 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG00013 affected63 at risk
EG00117 affected59 at risk
EG0024 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0013 affected59 at risk
EG0022 affected20 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0008 affected63 at risk
EG0014 affected59 at risk
EG0022 affected20 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0007 affected63 at risk
EG0018 affected59 at risk
EG0020 affected20 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0016 affected59 at risk
EG0021 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0021 affected20 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0013 affected59 at risk
EG0021 affected20 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0009 affected63 at risk
EG00111 affected59 at risk
EG0025 affected20 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0007 affected63 at risk
EG0018 affected59 at risk
EG0023 affected20 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0016 affected59 at risk
EG0021 affected20 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0016 affected59 at risk
EG0022 affected20 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0016 affected59 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0015 affected59 at risk
EG0022 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0007 affected63 at risk
EG0016 affected59 at risk
EG0023 affected20 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0007 affected63 at risk
EG00112 affected59 at risk
EG0024 affected20 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Cluster headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Cubital tunnel syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0007 affected63 at risk
EG00110 affected59 at risk
EG0023 affected20 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0013 affected59 at risk
EG0021 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG00010 affected63 at risk
EG0018 affected59 at risk
EG0026 affected20 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0012 affected59 at risk
EG0022 affected20 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0013 affected59 at risk
EG0022 affected20 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG00023 affected63 at risk
EG00127 affected59 at risk
EG0026 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected63 at risk
EG0011 affected59 at risk
EG0022 affected20 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0015 affected59 at risk
EG0021 affected20 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG00016 affected63 at risk
EG00117 affected59 at risk
EG00211 affected20 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Tremor
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0015 affected59 at risk
EG0021 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0014 affected59 at risk
EG0021 affected20 at risk
EG003
Hallucination olfactory
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG00015 affected63 at risk
EG0018 affected59 at risk
EG0023 affected20 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0013 affected59 at risk
EG0021 affected20 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0009 affected63 at risk
EG00115 affected59 at risk
EG0023 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0012 affected59 at risk
EG0021 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG00011 affected63 at risk
EG00111 affected59 at risk
EG0022 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0011 affected59 at risk
EG0022 affected20 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0012 affected59 at risk
EG0022 affected20 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0010 affected59 at risk
EG0023 affected20 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0013 affected59 at risk
EG0024 affected20 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0010 affected59 at risk
EG0022 affected20 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG00010 affected63 at risk
EG0017 affected59 at risk
EG0021 affected20 at risk
EG003
Brow ptosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0014 affected59 at risk
EG0020 affected20 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected63 at risk
EG0014 affected59 at risk
EG0023 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0016 affected59 at risk
EG0022 affected20 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Thrombolysis
Surgical and medical procedures
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Flushing
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected63 at risk
EG0010 affected59 at risk
EG0020 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0013 affected59 at risk
EG0020 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected63 at risk
EG0011 affected59 at risk
EG0021 affected20 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected63 at risk
EG0013 affected59 at risk
EG0020 affected20 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected63 at risk
EG0011 affected59 at risk
EG0024 affected20 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0011 affected59 at risk
EG0020 affected20 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0013 affected59 at risk
EG0020 affected20 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected63 at risk
EG0010 affected59 at risk
EG0021 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
20
OG00420
70.0
(49.22 to 86.04)
OG00475.0(54.44 to 89.59)
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00025
OG00113
OG00221
OG00314
OG00415
Title
Denominators
Categories
Title
Measurements
OG0006.24(0.89 to 22.57)
OG0016.47(0.03 to 23.52)
OG00213.37(0.03 to 35.68)
OG0039.36(0.03 to 19.35)
OG00412.85(0.03 to 22.11)
OG001
Cohort E (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0004
OG0012
OG00234
OG00327
Title
Denominators
Categories
Title
Measurements
OG0000(0.00 to 52.71)
OG00150.0(2.53 to 97.47)
OG00235.3(21.79 to 50.82)
OG0030(0.00 to 10.50)
OG001
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00060
OG0011
Title
Denominators
Categories
Baseline
ParticipantsOG00060
ParticipantsOG0010
Title
Measurements
OG0002
Post-baseline
ParticipantsOG00056
ParticipantsOG0011
Title
Measurements
OG0000
OG0010
OG001
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG004
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG005
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0002
OG00159
OG00220
OG0038
OG00437
OG00536
Title
Denominators
Categories
Baseline
ParticipantsOG0000
ParticipantsOG00159
ParticipantsOG00220
ParticipantsOG0038
ParticipantsOG00437
ParticipantsOG00536
Title
Measurements
OG0011
OG0020
OG0030
OG004
Post-baseline
ParticipantsOG0002
ParticipantsOG00153
ParticipantsOG00220
ParticipantsOG0036
OG001
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0009
OG00137
OG00239
Title
Denominators
Categories
Baseline
ParticipantsOG0009
ParticipantsOG00137
ParticipantsOG00239
Title
Measurements
OG0001
OG0012
OG0020
Post-baseline
ParticipantsOG0006
ParticipantsOG00136
ParticipantsOG00237
Title
Measurements
OG000
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00042
OG00121
OG00239
OG00320
OG00420
Title
Denominators
Categories
Title
Measurements
OG00085.7
OG00152.4
OG00276.9
OG00355.0
OG00460.0
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00042
OG00121
OG00239
OG00320
OG00420
Title
Denominators
Categories
Title
Measurements
OG0005.388(3.943 to 10.579)
OG00112.682(8.936 to 27.466)
OG0025.552(4.304 to 12.780)
OG00315.277(12.189 to 25.133)
OG00418.103(11.598 to 30.259)
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00042
OG00121
OG00239
OG00320
OG00420
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00123.8
OG00261.5
OG00315.0
OG00420.0
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00042
OG00121
OG00239
OG00320
OG00420
Title
Denominators
Categories
Title
Measurements
OG00016.493(7.458 to 32.460)
OG001NA(44.025 to NA)Median and Upper Limit of CI could not be estimated because very few participants (\<50%) had the event of interest.
OG00218.760(10.415 to 38.571)
OG003NA(NA to NA)Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.
OG004NA(NA to NA)Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.
OG001
Cohort E (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0004
OG0013
OG00236
OG00333
Title
Denominators
Categories
Title
Measurements
OG00025.0(1.27 to 75.14)
OG00166.7(13.54 to 98.30)
OG00233.3(20.49 to 48.34)
OG00315.2(6.17 to 29.25)
OG001
Cohort E (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0004
OG0012
OG00234
OG00327
Title
Denominators
Categories
Title
Measurements
OG00025.0(1.27 to 75.14)
OG001100.0(22.36 to 100.00)
OG00264.7(49.18 to 78.21)
OG00318.5(7.59 to 35.06)
OG001
Cohort E (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0004
OG0013
OG00236
OG00333
Title
Denominators
Categories
Title
Measurements
OG00025.0(1.27 to 75.14)
OG00166.7(13.54 to 98.30)
OG00263.9(48.83 to 77.15)
OG00321.2(10.40 to 36.18)
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00031
OG00136
Title
Denominators
Categories
Title
Measurements
OG0006.5(1.2 to 19.0)
OG00113.9(5.6 to 27.0)
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00037
OG00139
Title
Denominators
Categories
Title
Measurements
OG00010.8(3.8 to 23.1)
OG00120.5(10.6 to 34.0)
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00031
OG00136
Title
Denominators
Categories
Title
Measurements
OG00025.8(13.5 to 41.8)
OG00166.7(51.7 to 79.5)
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00037
OG00139
Title
Denominators
Categories
Title
Measurements
OG00021.6(11.2 to 35.6)
OG00164.1(49.7 to 76.8)
OG001
Cohort E (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG002
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
OG003
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG0005
OG0014
OG00239
OG00339
Title
Denominators
Categories
Title
Measurements
OG00020.0(1.02 to 65.74)
OG00150.0(9.76 to 90.24)
OG00274.4(60.40 to 85.38)
OG00343.6(30.00 to 57.94)
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00025
OG00115
OG00226
OG00311
OG00415
Title
Denominators
Categories
Title
Measurements
OG0005640± 8320
OG0013350± 1180
OG0024200± 2620
OG0033910± 2480
OG0042660± 879
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00036
OG00118
OG00235
OG00316
OG00418
Title
Denominators
Categories
Title
Measurements
OG000217± 61.5
OG001225± 40.9
OG002232± 72.7
OG003228± 83.3
OG004227± 32.4
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00025
OG00115
OG00226
OG00311
OG00415
Title
Denominators
Categories
Title
Measurements
OG000113.97± 61.41
OG001124.53± 41.12
OG002116.26± 59.99
OG003134.31± 97.45
OG004158.57± 60.47
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00025
OG00115
OG00226
OG00311
OG00415
Title
Denominators
Categories
Title
Measurements
OG00035.3± 56.3
OG00118.7± 6.23
OG00225.6± 18.0
OG00319.8± 7.34
OG00414.4± 3.62
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG002
Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG003
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
OG004
Cohort C (FL): RTX + Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00025
OG00115
OG00226
OG00311
OG00415
Title
Denominators
Categories
Title
Measurements
OG0002901.85± 1009.31
OG0012802.96± 678.33
OG0022988.90± 788.89
OG0032839.26± 730.10
OG0042654.46± 413.19
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00027
OG00115
Title
Denominators
Categories
Title
Measurements
OG000309± 67.7
OG001315± 111
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00117
Title
Denominators
Categories
Title
Measurements
OG0002840± 555
OG0013110± 828
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00121
Title
Denominators
Categories
Title
Measurements
OG00034.2± 24.0
OG00133.5± 17.5
OG001
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00120
Title
Denominators
Categories
Title
Measurements
OG00042.5± 11.6
OG00148.3± 9.34
Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00038
OG00121
Title
Denominators
Categories
Title
Measurements
OG000850± 222
OG001994± 190
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00121
Title
Denominators
Categories
Title
Measurements
OG0004.39± 3.15
OG0014.20± 2.32
OG001
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00026
OG00117
Title
Denominators
Categories
Title
Measurements
OG000412± 108
OG001428± 106
OG001
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00030
OG00117
Title
Denominators
Categories
Title
Measurements
OG0003660± 843
OG0013510± 1160
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00118
Title
Denominators
Categories
Title
Measurements
OG00031.7± 17.2
OG00129.5± 25.0
OG001
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00038
OG00116
Title
Denominators
Categories
Title
Measurements
OG00051.9± 12.3
OG00155.9± 12.8
OG001
Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00038
OG00117
Title
Denominators
Categories
Title
Measurements
OG000948± 204
OG001968± 268
Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
Units
Counts
Participants
OG00039
OG00118
Title
Denominators
Categories
Title
Measurements
OG0003.72± 1.98
OG0013.29± 2.71
Units
Counts
Participants
OG00017
Title
Denominators
Categories
Title
Measurements
OG000258± 84.1
Participants
OG00015
Title
Denominators
Categories
Title
Measurements
OG0002600± 630
OG00020
Title
Denominators
Categories
Title
Measurements
OG00017.7± 9.39
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG00042.2± 7.92
Participants
OG00017
Title
Denominators
Categories
Title
Measurements
OG000787± 113
OG00020
Title
Denominators
Categories
Title
Measurements
OG0002.02± 1.34
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00027
OG00130
Title
Denominators
Categories
Title
Measurements
OG000218± 89.1
OG001215± 102
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00026
OG00129
Title
Denominators
Categories
Title
Measurements
OG0002440± 665
OG0012340± 875
Units
Counts
Participants
OG00040
OG00141
Title
Denominators
Categories
Title
Measurements
OG00027.9± 21.3
OG00122.3± 9.46
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00037
OG00138
Title
Denominators
Categories
Title
Measurements
OG00035.0± 9.89
OG00134.2± 7.89
Units
Counts
Participants
OG00033
OG00133
Title
Denominators
Categories
Title
Measurements
OG000711± 155
OG001694± 161
Units
Counts
Participants
OG00040
OG00141
Title
Denominators
Categories
Title
Measurements
OG0003.62± 3.73
OG0012.80± 1.30
Units
Counts
Participants
OG00040
OG00135
Title
Denominators
Categories
Title
Measurements
OG000340± 95.0
OG001330± 87.9
Units
Counts
Participants
OG00035
OG0019
Title
Denominators
Categories
Title
Measurements
OG00010.5(5.5 to 16.7)
OG001NA(38.4 to NA)Median and corresponding CI could not be estimated because very few participants (\<50%) had the event of interest.
Units
Counts
Participants
OG00045
OG00144
Title
Denominators
Categories
Title
Measurements
OG00077.8
OG00120.5
OG001
Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
Units
Counts
Participants
OG00045
OG00144
Title
Denominators
Categories
Title
Measurements
OG0002.7(2.1 to 5.9)
OG00119.5(10.9 to 38.4)
Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.