A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin,... | NCT02611323 | Trialant
NCT02611323
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Oct 10, 2023Actual
Enrollment
133Actual
Phase
Phase 1Phase 2
Conditions
Non-Hodgkin's Lymphoma
Interventions
Obinutuzumab
Rituximab
Polatuzumab Vedotin
Venetoclax
Countries
United States
Australia
Italy
Protocol Section
Identification Module
NCT ID
NCT02611323
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO29833
Secondary IDs
ID
Type
Description
Link
2015-001998-40
EudraCT Number
Brief Title
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title
A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Sep 2023
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
Mar 9, 2016Actual
Primary Completion Date
Aug 4, 2022Actual
Completion Date
Aug 4, 2022Actual
First Submitted Date
Nov 19, 2015
First Submission Date that Met QC Criteria
Nov 19, 2015
First Posted Date
Nov 20, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 28, 2023
Results First Submitted that Met QC Criteria
Sep 15, 2023
Results First Posted Date
Oct 10, 2023Actual
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
Sep 15, 2023
Last Update Posted Date
Oct 10, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.
Detailed Description
Not provided
Conditions Module
Conditions
Non-Hodgkin's 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
133Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose-Escalation Cohort: FL
Experimental
Participants with relapsed or refractory FL will receive 18 weeks of induction treatment with polatuzumab vedotin and venetoclax at escalating doses to identify the recommended Phase 2 dose (RP2D) for polatuzumab vedotin and venetoclax when combined with a fixed dose of obinutuzumab. Those who achieve CR, PR, or SD at the EOI will be eligible to receive a 24-month maintenance regimen consisting of 8 months of venetoclax and 24 months of obinutuzumab.
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Venetoclax
Dose-Escalation Cohort: DLBCL
Experimental
Participants with relapsed or refractory DLBCL will receive 18 weeks of induction treatment. Venetoclax will be administered at escalating doses to identify the RP2D of venetoclax when combined with fixed doses of polatuzumab vedotin and rituximab. Those who achieve CR or PR at the EOI will be eligible to receive an 8-month consolidation regimen consisting of venetoclax and rituximab.
Drug: Rituximab
Drug: Polatuzumab Vedotin
Drug: Venetoclax
Expansion Cohort: FL
Experimental
Participants with relapsed or refractory FL will receive 18 weeks of induction treatment with polatuzumab vedotin and venetoclax at the RP2D identified during the dose-escalation phase, in addition to obinutuzumab. Those who achieve CR, PR, or SD at the EOI will be eligible to receive a 24-month maintenance regimen consisting of 8 months of venetoclax and 24 months of obinutuzumab.
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Venetoclax
Expansion Cohort: DLBCL
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Obinutuzumab
Drug
Participants will receive a fixed dose of obinutuzumab, 1000 milligrams (mg) via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 1000 mg via IV infusion on Day 1 of every other month (starting from Month 2) for up to 24 months, until disease progression or unacceptable toxicity.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With CR at EOI Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans
CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions. No new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21 days)
FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). Percentages have been rounded off to the first decimal point.
From study start to 24 months after last dose of study drug (approximately 56 months)
DLBCL Cohorts: Percentage of Participants With AEs and SAEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the NCI-CTCAE, v4.0. Percentages have been rounded off to the first decimal point.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans
CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions; no evidence of FDG-avid disease in bone marrow. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
For obinutuzumab + polatuzumab vedotin + venetoclax treatment group, relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-cluster of differentiation 20 (CD20) (anti-CD20) monoclonal antibody (mAb) and for which no other more appropriate treatment option exists, as determined by the investigator
For rituximab + polatuzumab vedotin + venetoclax treatment group, relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 mAb and for which no curative option exists as determined by the investigator
At least one bidimensionally measurable lesion
Exclusion Criteria:
Known CD20-negative status at relapse or progression
Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
Grade 3b FL
History of transformation of indolent disease to DLBCL
Current use of systemic corticosteroids greater than (>) 20 mg prednisone per day (or equivalent); or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Central nervous system (CNS) disease
Active infection
Actual or potential cytochrome P450 (CYP) 3A interactions including: requirement for warfarin; use of strong and moderate CYP3A inhibitors or inducers within 7 days prior to first dose of venetoclax; or consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first dose of venetoclax
Positive for human immunodeficiency virus (HIV) or hepatitis B or C
Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
Poor hematologic, renal, or hepatic function
Pregnant or lactating women
Life expectancy <3 months
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Arizona Cancer Center
Tucson
Arizona
85719
United States
Yale Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 133 participants with relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) were enrolled in this study. Out of the 133, two participants did not receive any study treatment. Of the 131 treated participants, 74 participants with FL received Obinutuzumab (G) in combination with polatuzumab vedotin (P) and venetoclax (V) and 57 participants with DLBCL received rituximab (R) in combination with polatuzumab vedotin and venetoclax.
Recruitment Details
Participants took part in this study at 23 investigative centers in Australia, Italy, and the United States from 09 March 2016 up to 04 August 2022. The study consisted of two phases: a dose-escalation phase and a dose-expansion phase. All eligible participants in both dose-escalation and expansion phases received induction treatment, and post-induction treatment as indicated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 milligrams (mg), orally, once daily (QD) on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, intravenous (IV) infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 milligrams per kilograms (mg/kg), IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
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
Jan 17, 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
Non-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
Experimental
Participants with relapsed or refractory DLBCL will receive 18 weeks of induction treatment. Venetoclax will be administered at the RP2D identified during the dose-escalation phase, in addition to polatuzumab vedotin and rituximab. Those who achieve CR or PR at the EOI will be eligible to receive an 8-month consolidation regimen consisting of venetoclax and rituximab.
Drug: Rituximab
Drug: Polatuzumab Vedotin
Drug: Venetoclax
Dose-Escalation Cohort: FL
Expansion Cohort: FL
Rituximab
Drug
Participants will receive a fixed dose of rituximab, 375 milligrams per square meter (mg/m^2) via IV infusion to be given on Day 1 of Cycles 1 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 375 mg/m^2 via IV infusion on Day 1 of every other month (starting from Month 2) for up to 8 months, until disease progression or unacceptable toxicity.
Dose-Escalation Cohort: DLBCL
Expansion Cohort: DLBCL
Polatuzumab Vedotin
Drug
Participants will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) (for FL), and 1.8 mg/kg (for DLBCL) on Day 1 of each 21-day cycle for up to 18 weeks during induction treatment. Polatuzumab vedotin will not be given during the post-induction period.
Dose-Escalation Cohort: DLBCL
Dose-Escalation Cohort: FL
Expansion Cohort: DLBCL
Expansion Cohort: FL
Venetoclax
Drug
Participants will receive venetoclax film-coated tablets at doses of 200, 400, 600, or 800 mg (for FL), and 400, 600, or 800 mg (for DLBCL) on Days 1 to 21 of each 21-day cycle. Post-induction venetoclax may continue for up to 8 months, until disease progression or unacceptable toxicity.
Dose-Escalation Cohort: DLBCL
Dose-Escalation Cohort: FL
Expansion Cohort: DLBCL
Expansion Cohort: FL
From study start to 3 months after last dose of study drug (approximately 21 months)
Number of Participants With Dose-Limiting Toxicities (DLTs)
DLT=any one of the events that occurred in first treatment cycle & per the investigator was related to study treatment. Any AE that lead to a delay of > 14 days in start of next treatment cycle; Any Grade 3/4 non-hematologic AE with few exceptions; Any increase in hepatic transaminase >3×baseline(BL) & increase in direct bilirubin >2×upper limit of normal (ULN), without any findings of cholestasis/jaundice/signs of hepatic dysfunction & in absence of other contributory factors; Grade1 alanine transaminase (ALT)/aspartate transaminase (AST) elevation at BL as result of liver metastases, only a Grade ≥3 elevation, also ≥3×BL lasting >7 days; Hematologic AE meeting protocol specified criteria. Events were graded per NCI CTCAE v4.0. Grade 1:Mild; asymptomatic/mild symptoms; Grade 2:Moderate;minimal,local/non-invasive intervention indicated; Grade 3:Severe/medically significant, but not immediately life-threatening; Grade 4:Life-threatening consequences/urgent intervention indicated.
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
RP2D of Polatuzumab Vedotin
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of polatuzumab vedotin when given in combination with fixed dose of obinutuzumab in participants with FL was determined.
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
RP2D of Venetoclax
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of venetoclax when given in combination with fixed dose of polatuzumab vedotin in participants with FL and DLBCL was determined.
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone
CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With Objective Response (OR) at EOI, Determined by an IRC on the Basis of PET and CT Scans
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes & ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake> mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions & no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of PET and CT Scans
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes & ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake> mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions;no new lesions & no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With OR at EOI, Determined by an IRC on the Basis of CT Scans Alone
OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
OR was defined as the percentage of participants with CR or PR, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
Percentage of Participants With Best Overall Response (BOR) of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone
BOR=CR or PR as assessed by investigator per CT per MLRC. Per MLRC, CR based on CT was defined as a complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. Percentages have been rounded off to the first decimal point.
Up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months)
Observed Serum Obinutuzumab Concentration
Pre-dose & 0.5 hours post-dose on Day 1 Cycles 1, 2, 4, & 6; and pre-dose on Day 1 of Months 2, 8, 14, 20; study drug discontinuation, Day 120 &1 year post-last dose (up to approximately 40 months) (1 cycle = 21 days)
Observed Serum Rituximab Concentration
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1 and 6; pre-dose on Day 1 of Cycles 2 and 4; (1 cycle = 21 days)
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Total antibody is an analyte of polatuzumab vedotin.
Pre-dose on Day 1 of Cycles 1, 2 and 4; study drug discontinuation visit; Day 120 and 1 year post-last dose (up to approximately 16 months) (1 cycle=21 days)
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
acMMAE is an analyte of polatuzumab vedotin.
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
MMAE is an analyte of polatuzumab vedotin.
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)
Observed Plasma Venetoclax Concentration
Pre-dose and 4 hours post-dose on Day 1 Cycle 1, pre-dose & 2, 4, 6, & 8 hours post-dose on Day 1 Cycle 2, pre-dose & 4hours post-dose on Day 1 Cycle 4 & pre-dose on Day 1 Cycle 6; (1 cycle = 21 days)
Number of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
The number of participants with positive results for HAHAs, also called anti-drug antibodies (ADAs) against obinutuzumab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.
Baseline up to approximately 2 years after last dose (up to approximately 56 months)
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Polatuzumab Vedotin
The number of participants with positive results for ATAs, also called ADAs against polatuzumab vedotin at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.
Baseline up to 1 year post last dose (up to approximately 16 months)
New Haven
Connecticut
06520
United States
Memorial Healthcare System
Pembroke
Florida
33028
United States
Emory Univ Winship Cancer Inst
Atlanta
Georgia
30322
United States
University of Louisville Hospital; The James Graham Brown Cancer Center
Louisville
Kentucky
40202
United States
University of Michigan
Ann Arbor
Michigan
48109-0934
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08901
United States
Roswell Park Cancer Inst.
Buffalo
New York
14263
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Scott and White
Temple
Texas
76508
United States
Royal North Shore Hospital; Haematology Department
St Leonards
New South Wales
2065
Australia
Calvary Mater Newcastle
Waratah
New South Wales
2298
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
The Queen Elizabeth Hospital
Adelaide
South Australia
5011
Australia
Royal Hobart Hospital
Hobart
Tasmania
7000
Australia
Peter MacCallum Cancer Center
North Melbourne
Victoria
3051
Australia
Papa Giovanni Hospital XXIII
Bergamo
Emilia-Romagna
24127
Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola
Emilia-Romagna
47014
Italy
UO Ematologia, Ospedale S.Maria delle Croci
Ravenna
Emilia-Romagna
48121
Italy
Ospedale Infermi U.O. Ematologia
Rimini
Emilia-Romagna
47923
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Lombardy
20133
Italy
SCDU Ematologia
Novara
Piedmont
28100
Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Turin
Piedmont
10126
Italy
FG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
FG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
FG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
FG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
FG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
FG0007 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0049 subjects
FG0058 subjects
FG00641 subjects
FG0073 subjects
FG0086 subjects
FG0098 subjects
FG01040 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0048 subjects
FG0057 subjects
FG00630 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG01011 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG00611 subjects
FG0071 subjects
FG0084 subjects
FG0098 subjects
FG01029 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0068 subjects
FG0070 subjects
FG0084 subjects
FG0096 subjects
FG01026 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Found Another Malignancy After Starting Trial
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
BG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
BG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
BG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
BG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0013
BG0023
BG0033
BG0049
BG0058
BG00641
BG0073
BG0086
BG0098
BG01040
BG011131
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.9± 6.8
BG00161.3± 8.5
BG00256.7± 13.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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 CR at EOI Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans
CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions. No new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at recommended phase 2 dose (RP2D) in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000100(68.77 to 100.00)
OG00151.2(37.44 to 64.86)
OG00225(4.64 to 59.97)
OG003
Primary
FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). Percentages have been rounded off to the first decimal point.
Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure.
Posted
Number
percentage of participants
From study start to 24 months after last dose of study drug (approximately 56 months)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Primary
DLBCL Cohorts: Percentage of Participants With AEs and SAEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the NCI-CTCAE, v4.0. Percentages have been rounded off to the first decimal point.
Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure.
Posted
Number
percentage of participants
From study start to 3 months after last dose of study drug (approximately 21 months)
ID
Title
Description
OG000
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs)
DLT=any one of the events that occurred in first treatment cycle & per the investigator was related to study treatment. Any AE that lead to a delay of > 14 days in start of next treatment cycle; Any Grade 3/4 non-hematologic AE with few exceptions; Any increase in hepatic transaminase >3×baseline(BL) & increase in direct bilirubin >2×upper limit of normal (ULN), without any findings of cholestasis/jaundice/signs of hepatic dysfunction & in absence of other contributory factors; Grade1 alanine transaminase (ALT)/aspartate transaminase (AST) elevation at BL as result of liver metastases, only a Grade ≥3 elevation, also ≥3×BL lasting >7 days; Hematologic AE meeting protocol specified criteria. Events were graded per NCI CTCAE v4.0. Grade 1:Mild; asymptomatic/mild symptoms; Grade 2:Moderate;minimal,local/non-invasive intervention indicated; Grade 3:Severe/medically significant, but not immediately life-threatening; Grade 4:Life-threatening consequences/urgent intervention indicated.
Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the dose-escalation cohorts cohorts were assessed in this outcome measure.
Posted
Count of Participants
Participants
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Primary
RP2D of Polatuzumab Vedotin
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of polatuzumab vedotin when given in combination with fixed dose of obinutuzumab in participants with FL was determined.
Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure.
Posted
Number
mg/kg
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
ID
Title
Description
OG000
All FL Participants: Dose Escalation
All participants with FL received venetoclax, at a dose of 200 mg, 400 mg, 600 mg or 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) in combination with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, at a dose of 1.4 mg/kg or 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, at a dose of 200 mg, 400 mg, 600 mg or 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Units
Primary
RP2D of Venetoclax
RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of venetoclax when given in combination with fixed dose of polatuzumab vedotin in participants with FL and DLBCL was determined.
Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure.
Posted
Number
mg
Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase
ID
Title
Description
OG000
All FL Participants: Dose Escalation
All participants with FL received venetoclax, at a dose of 200 mg, 400 mg, 600 mg or 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) in combination with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, at a dose of 1.4 mg/kg or 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, at a dose of 200 mg, 400 mg, 600 mg or 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
All DLBCL Participants: Dose Escalation
Secondary
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans
CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions; no evidence of FDG-avid disease in bone marrow. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone
CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With Objective Response (OR) at EOI, Determined by an IRC on the Basis of PET and CT Scans
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes & ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake> mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions & no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of PET and CT Scans
OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes & ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake> mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions;no new lesions & no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With OR at EOI, Determined by an IRC on the Basis of CT Scans Alone
OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of CT Scans Alone
OR was defined as the percentage of participants with CR or PR, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Percentage of Participants With Best Overall Response (BOR) of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone
BOR=CR or PR as assessed by investigator per CT per MLRC. Per MLRC, CR based on CT was defined as a complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal, no new sites of lesions. Percentages have been rounded off to the first decimal point.
Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months)
ID
Title
Description
OG000
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Observed Serum Obinutuzumab Concentration
Pharmacokinetics (PK) evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (µg/mL)
Pre-dose & 0.5 hours post-dose on Day 1 Cycles 1, 2, 4, & 6; and pre-dose on Day 1 of Months 2, 8, 14, 20; study drug discontinuation, Day 120 &1 year post-last dose (up to approximately 40 months) (1 cycle = 21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Observed Serum Rituximab Concentration
PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1 and 6; pre-dose on Day 1 of Cycles 2 and 4; (1 cycle = 21 days)
ID
Title
Description
OG000
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG001
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Secondary
Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin
Total antibody is an analyte of polatuzumab vedotin.
PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Pre-dose on Day 1 of Cycles 1, 2 and 4; study drug discontinuation visit; Day 120 and 1 year post-last dose (up to approximately 16 months) (1 cycle=21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL Dose Escalation: 1.4P+200V+1000G
Secondary
Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE)
acMMAE is an analyte of polatuzumab vedotin.
PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL Dose Escalation: 1.4P+200V+1000G
Secondary
Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
MMAE is an analyte of polatuzumab vedotin.
PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Observed Plasma Venetoclax Concentration
PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Pre-dose and 4 hours post-dose on Day 1 Cycle 1, pre-dose & 2, 4, 6, & 8 hours post-dose on Day 1 Cycle 2, pre-dose & 4hours post-dose on Day 1 Cycle 4 & pre-dose on Day 1 Cycle 6; (1 cycle = 21 days)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Number of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
The number of participants with positive results for HAHAs, also called anti-drug antibodies (ADAs) against obinutuzumab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.
The immunogenicity population included participants with at least one predose and one postdose HAHA or ATA assessment, with participants grouped according to histology. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Count of Participants
Participants
Baseline up to approximately 2 years after last dose (up to approximately 56 months)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Secondary
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Polatuzumab Vedotin
The number of participants with positive results for ATAs, also called ADAs against polatuzumab vedotin at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.
Immunogenicity population included participants with at least one predose and one postdose HAHA or ATA assessment, with participants grouped according to histology. Number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
Baseline up to 1 year post last dose (up to approximately 16 months)
ID
Title
Description
OG000
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Time Frame
FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months)
Description
Safety-evaluable population included all participants who received at least one dose of any component of the combination.
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
FL Dose Escalation: 1.4P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
3
7
4
7
7
7
EG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
1
3
1
3
3
3
EG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
0
3
1
3
3
3
EG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
0
3
0
3
3
3
EG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
1
9
2
9
9
9
EG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
1
8
6
8
8
8
EG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
8
41
14
41
41
41
EG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
0
3
3
3
3
3
EG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
4
6
4
6
6
6
EG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
6
8
2
8
7
8
EG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
26
40
12
40
38
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CARDIOMYOPATHY
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RETINAL TEAR
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ADVERSE DRUG REACTION
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LIVER INJURY
Hepatobiliary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPENIC SEPSIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0008 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PSEUDOMONAS INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ULNA FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERVOLAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ENCEPHALOPATHY
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DEVICE LEAKAGE
Product Issues
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHIECTASIS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0003 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0056 events2 affected8 at risk
EG00613 events7 affected41 at risk
EG0071 events1 affected3 at risk
EG0083 events2 affected6 at risk
EG0094 events3 affected8 at risk
EG0109 events5 affected40 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERGAMMAGLOBULINAEMIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0013 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version: 25
Systematic Assessment
EG0004 events3 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CORONARY ARTERY OCCLUSION
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DEAFNESS
Ear and labyrinth disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OTORRHOEA
Ear and labyrinth disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CATARACT
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DIPLOPIA
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
EYE PAIN
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SCLERAL HYPERAEMIA
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0006 events3 affected7 at risk
EG0012 events2 affected3 at risk
EG0027 events3 affected3 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FAECES DISCOLOURED
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FAECES SOFT
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GASTROINTESTINAL DISORDER
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GASTROINTESTINAL PAIN
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUCOUS STOOLS
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
ODYNOPHAGIA
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ORAL DISCHARGE
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
ADVERSE DRUG REACTION
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ASTHENIA
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CHEST PAIN
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CHILLS
General disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
EARLY SATIETY
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA version: 25
Systematic Assessment
EG0007 events5 affected7 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected3 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INJECTION SITE BRUISING
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
INJECTION SITE EXTRAVASATION
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MALAISE
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA MUCOSAL
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PAIN
General disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERTRANSAMINASAEMIA
Hepatobiliary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CYTOKINE RELEASE SYNDROME
Immune system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BACTERIAL DISEASE CARRIER
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG00012 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CAMPYLOBACTER INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
CHRONIC SINUSITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GASTROINTESTINAL VIRAL INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RHINITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0004 events4 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
URINARY TRACT INFECTION ENTEROCOCCAL
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HAND FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INCISIONAL HERNIA
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PERIORBITAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN WOUND
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SUNBURN
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VASCULAR ACCESS SITE PAIN
Injury, poisoning and procedural complications
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BILIRUBIN CONJUGATED INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD CALCIUM DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD CALCIUM INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD FIBRINOGEN DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD IMMUNOGLOBULIN G DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD PHOSPHORUS DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INFLUENZA A VIRUS TEST POSITIVE
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OCCULT BLOOD POSITIVE
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PROTEIN TOTAL DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PROTEIN URINE PRESENT
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RED BLOOD CELLS URINE POSITIVE
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
URINARY CASTS PRESENT
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
JOINT STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL DISCOMFORT
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OSTEOPENIA
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PLANTAR FASCIITIS
Musculoskeletal and connective tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OCULAR MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OCULAR SURFACE SQUAMOUS NEOPLASIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
SKIN CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
APHASIA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0003 events2 affected7 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RESTING TREMOR
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TASTE DISORDER
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
TREMOR
Nervous system disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HALLUCINATION
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
LIBIDO DECREASED
Psychiatric disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
URINE ABNORMALITY
Renal and urinary disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ANISOMASTIA
Reproductive system and breast disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BREAST CYST
Reproductive system and breast disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
BREAST PAIN
Reproductive system and breast disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ENDOMETRIAL THICKENING
Reproductive system and breast disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PROSTATIC DISORDER
Reproductive system and breast disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ATELECTASIS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0008 events3 affected7 at risk
EG0011 events1 affected3 at risk
EG0023 events1 affected3 at risk
EG003
DRY THROAT
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0003 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
LARYNGEAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PULMONARY CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PULMONARY MASS
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0002 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
SINUS PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
THROAT IRRITATION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
UPPER RESPIRATORY TRACT INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
COLD SWEAT
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DERMATITIS ALLERGIC
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERKERATOSIS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
MILIARIA
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
ONYCHOMADESIS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN HYPERTROPHY
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SOLAR LENTIGO
Skin and subcutaneous tissue disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0025 events1 affected3 at risk
EG003
TOOTH EXTRACTION
Surgical and medical procedures
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
FLUSHING
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
POOR VENOUS ACCESS
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
SUPERFICIAL VEIN THROMBOSIS
Vascular disorders
MedDRA version: 25
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 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 received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
40
32.5
(20.41 to 46.63)
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00641
Title
Denominators
Categories
AEs
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
OG006100
SAEs
Title
Measurements
OG00057.1
OG00133.3
OG00233.3
OG003
OG001
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0003
OG0016
OG0028
OG00340
Title
Denominators
Categories
AEs
Title
Measurements
OG000100
OG001100
OG00287.5
OG00397.5
SAEs
Title
Measurements
OG000100
OG00166.7
OG00225.0
OG003
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG007
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG0063
OG0076
OG0088
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0042
OG0051
OG0060
OG0071
OG0080
Counts
Participants
OG00033
Title
Denominators
Categories
Title
Measurements
OG0001.8
All participants with DLBCL received venetoclax, at a dose of 400 mg, 600 mg or 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, at a dose of 400 mg, 600 mg or 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG00033
OG00117
Title
Denominators
Categories
Title
Measurements
OG000800
OG001800
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG000100(68.77 to 100.00)
OG00151.2(37.44 to 64.86)
OG00225.0(4.64 to 59.97)
OG00332.5(20.41 to 46.63)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0026
OG00334
Title
Denominators
Categories
Title
Measurements
OG00062.5(28.92 to 88.89)
OG00136.6(24.08 to 50.61)
OG00216.7(0.85 to 58.18)
OG00326.5(14.56 to 41.65)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG00075.0(40.03 to 95.36)
OG00129.3(17.84 to 43.07)
OG00225.0(4.64 to 59.97)
OG00322.5(12.27 to 35.98)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG000100.0(68.77 to 100.00)
OG00170.7(56.93 to 82.16)
OG00225.0(4.64 to 59.97)
OG00337.5(24.73 to 51.72)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG000100.0(68.77 to 100.00)
OG00175.6(62.15 to 86.13)
OG00237.5(11.11 to 71.08)
OG00342.5(29.18 to 56.69)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG00087.5(52.93 to 99.36)
OG00182.9(70.31 to 91.70)
OG00225.0(4.64 to 59.97)
OG00337.5(24.73 to 51.72)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG00087.5(52.93 to 99.36)
OG00185.4(73.15 to 93.43)
OG00237.5(11.11 to 71.08)
OG00345.0(31.46 to 59.12)
OG001
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0008
OG00141
OG0028
OG00340
Title
Denominators
Categories
Title
Measurements
OG000100.0(68.77 to 100.00)
OG00187.8(76.05 to 95.07)
OG00250.0(19.29 to 80.71)
OG00372.5(58.61 to 83.75)
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00639
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00629
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were below lower limit of quantification (BLLQ).
OG001NA± NAThe data was not evaluable as the samples were BLLQ.
OG002NA± NAThe data was not evaluable as the samples were BLLQ.
OG003
Cycle 1 Day 1: 0.5 hours Post Dose
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 4 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 4 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 6 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 6 Day 1: 0.5 hours Post Dose
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Maintenance Month 2
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Maintenance Month 8
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Maintenance Month 14
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Maintenance Month 20
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0030
Study Drug Discontinuation Visit
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Day 120 Post Last Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
One Year Post Last Dose
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG002
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG003
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0002
OG0016
OG0026
OG00339
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0039
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were BLLQ.
OG001NA± NAThe data was not evaluable as the samples were BLLQ.
OG002NA± NAThe data was not evaluable as the samples were BLLQ.
OG003
Cycle 1 Day 1: 0.5 hours Post Dose
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00339
Cycle 2 Day 1: Pre-dose
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00336
Cycle 4 Day 1:Pre-dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG00329
Cycle 6 Day 1: Pre-dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG00324
Cycle 6 Day 1: 0.5 hours Post Dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG00323
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0048
OG0058
OG00641
OG0073
OG0086
OG0097
OG01039
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00641
ParticipantsOG0072
ParticipantsOG0086
ParticipantsOG0097
ParticipantsOG01039
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were BLLQ.
OG001NA± NAThe data was not evaluable as the samples were BLLQ.
OG002NA± NAThe data was not evaluable as the samples were BLLQ.
OG003
Cycle 2 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 4 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Study Drug Discontinuation Visit
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Day 120 Post Last Dose
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
One Year Post Last Dose
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00640
OG0073
OG0086
OG0098
OG01039
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00640
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0098
ParticipantsOG01039
Title
Measurements
OG000NA± NAThe data is not evaluable as the samples were BLLQ.
OG001NA± NAThe data is not evaluable as the samples were BLLQ.
OG002NA± NAThe data is not evaluable as the samples were BLLQ.
OG003
Cycle 1 Day 1: 0.5 hours Post Dose
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 8: Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 15: Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 4 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 4 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 6 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00640
OG0073
OG0086
OG0098
OG01038
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0098
ParticipantsOG01038
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were BLLQ.
OG001NA± NAThe data was not evaluable as the samples were BLLQ.
OG002NA± NAThe data was not evaluable as the samples were BLLQ.
OG003
Cycle 1 Day 1: 0.5 hours Post Dose
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 8: Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 15: Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 4 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 4 Day 1: 0.5 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 6 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00641
OG0073
OG0086
OG0097
OG01040
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
Title
Measurements
OG010NA± NAThe data was not evaluable as the samples were BLLQ.
Cycle 1 Day 1: Post Dose
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 2 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Cycle 2 Day 1: 4 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 6 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Cycle 2 Day 1: 8 hours Post Dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Cycle 4 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 4 Day 1: Post Dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 6 Day 1: Pre-dose
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00639
Title
Denominators
Categories
Baseline prevalence of ADAs
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG00639
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post baseline incidence of ADAs
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG001
FL Dose Escalation: 1.4P+200V+1000G
Participants received venetoclax, 200 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 200 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG002
FL Dose Escalation: 1.4P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.4 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG003
FL Dose Escalation: 1.8P+400V+1000G
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 400 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG004
FL Dose Escalation: 1.8P+600V+1000G
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 600 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG005
FL Dose Escalation: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG006
FL: Dose Expansion: 1.8P+800V+1000G
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with obinutuzumab, 1000 mg, IV infusion, on Days 1, 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received venetoclax, 800 mg, QD, for up to 8 months and obinutuzumab, 1000 mg on Day 1 of every other month (1 month=28 days) starting from Month 2 for up to 24 months.
OG007
DLBCL: Dose Escalation: 1.8P+400V+375R
Participants received venetoclax, 400 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 milligrams per square meter (mg/m^2), IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 400 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG008
DLBCL Dose Escalation: 1.8P+600V+375R
Participants received venetoclax, 600 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 600 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG009
DLBCL Dose Escalation: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
OG010
DLBCL Dose Expansion: 1.8P+800V+375R
Participants received venetoclax, 800 mg, orally, QD on Days 1-21 of Cycles 1-6 (1 cycle=21 days) along with rituximab, 375 mg/m^2, IV infusion, on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, IV infusion, on Day 1 of Cycles 1-6 as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 8 months. During consolidation treatment participants received venetoclax, 800 mg, QD, for up to 8 months and rituximab, 375 mg/m^2 on Day 1 of every other month (1 month=28 days) starting from Month 2 up to 8 months.
Units
Counts
Participants
OG0007
OG0013
OG0023
OG0033
OG0049
OG0058
OG00641
OG0073
OG0086
OG0098
OG01040
Title
Denominators
Categories
Baseline prevalence of ADAs
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG00641
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0098
ParticipantsOG01040
Title
Measurements
OG0001
OG0010
OG0020
OG003
Post baseline incidence of ADAs
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0053 events1 affected8 at risk
EG0063 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0102 events2 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0102 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0102 events2 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected8 at risk
EG0063 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0052 events1 affected8 at risk
EG0064 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0109 events3 affected40 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
5 events
1 affected
3 at risk
EG00417 events4 affected9 at risk
EG00523 events5 affected8 at risk
EG00646 events17 affected41 at risk
EG0075 events2 affected3 at risk
EG0087 events2 affected6 at risk
EG0097 events5 affected8 at risk
EG01064 events20 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected9 at risk
EG0058 events4 affected8 at risk
EG00637 events12 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0108 events6 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
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2 events
1 affected
3 at risk
EG0042 events2 affected9 at risk
EG0053 events3 affected8 at risk
EG00611 events11 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0105 events5 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events5 affected41 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0104 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0066 events6 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0103 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0064 events2 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0103 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0103 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected8 at risk
EG0067 events6 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0104 events4 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0103 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
1 events
1 affected
3 at risk
EG0043 events3 affected9 at risk
EG0057 events4 affected8 at risk
EG00614 events11 affected41 at risk
EG0072 events2 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG01011 events9 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0067 events6 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0105 events4 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events2 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0044 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0067 events5 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0052 events1 affected8 at risk
EG0064 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0105 events4 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0062 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0052 events2 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0102 events2 affected40 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected8 at risk
EG0063 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0103 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0052 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0062 events2 affected41 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected6 at risk
EG0091 events1 affected8 at risk
EG0103 events3 affected40 at risk
0 events
0 affected
3 at risk
EG0043 events2 affected9 at risk
EG0051 events1 affected8 at risk
EG0067 events4 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0102 events2 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected9 at risk
EG0052 events2 affected8 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0053 events1 affected8 at risk
EG0066 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events3 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected41 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected41 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected40 at risk
0
OG00422.2
OG00575.0
OG00634.1
30.0
NA
± NA
The data was not evaluable as the samples were BLLQ.
OG004NA± NAThe data was not evaluable as the samples were BLLQ.
OG005NA± NAThe data was not evaluable as the samples were BLLQ.
OG006NA± NAThe data was not evaluable as the samples were BLLQ.
ParticipantsOG0049
ParticipantsOG0055
ParticipantsOG00638
Title
Measurements
OG000310± 21.2
OG001360± 18.8
OG002169± 60.2
OG003342± 11.0
OG004262± 106.0
OG005438± 17.8
OG006261± 115.1
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
Title
Measurements
OG000327± 46.7
OG001498± 20.6
OG002288± 43.2
OG003395± 17.0
OG004435± 25.4
OG005497± 20.3
OG006422± 29.0
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
Title
Measurements
OG000637± 32.0
OG001822± 17.0
OG002512± 56.1
OG003685± 17.8
OG004800± 19.1
OG005975± 19.3
OG006834± 30.3
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
Title
Measurements
OG000284± 50.9
OG001496± 25.3
OG002376± 9.6
OG003337± 12.0
OG004422± 20.3
OG005454± 37.2
OG006397± 40.5
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
Title
Measurements
OG000534± 62.9
OG001842± 25.1
OG002709± 20.1
OG003732± 13.4
OG004819± 18.6
OG005925± 26.9
OG006770± 25.6
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
Title
Measurements
OG000288± 62.9
OG001582± 26.5
OG002338± 4.0
OG003335± 10.2
OG004437± 24.5
OG005420± 44.5
OG006428± 51.9
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
Title
Measurements
OG000582± 26.8
OG001887± 19.6
OG002490± 65.2
OG003659± 14.3
OG004857± 21.2
OG005841± 28.1
OG006807± 27.0
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00631
Title
Measurements
OG000117± 471.2
OG001294± 53.3
OG002205± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003192± 11.7
OG004273± 63.4
OG005327± 57.6
OG006291± 60.8
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG00620
Title
Measurements
OG000148± 161.8
OG001184± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG002191± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003114± 30.0
OG004170± 40.2
OG005210± 27.0
OG006168± 72.0
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG00614
Title
Measurements
OG000189± 112.9
OG001226± 28.9
OG002197± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003138± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG004133± 23.5
OG005190± 17.9
OG006168± 41.3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00612
Title
Measurements
OG000242± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG001218± 30.7
OG00274.0± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG004156± 44.2
OG005144± 26.9
OG006180± 62.0
ParticipantsOG0042
ParticipantsOG0054
ParticipantsOG00616
Title
Measurements
OG0009.61± 438943.9
OG001134± 1414.6
OG0024.48± 2973890.2
OG00366.6± 271.0
OG004262± 11.9
OG005212± 34.8
OG006148± 110.1
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG00610
Title
Measurements
OG00039.9± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0021.72± 1634893.3
OG0030.660± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00441.2± 89.5
OG00594.6± 85.6
OG00644.1± 274.2
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0066
Title
Measurements
OG0000.0410± 20351.2
OG0020.0585± 372.7
OG0030.00680± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0040.244± 716.1
OG0050.0820± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0064.89± 9002.8
NA
± NA
The data was not evaluable as the samples were BLLQ.
Title
Measurements
OG000199± 25.4
OG001189± 6.8
OG002255± 14.0
OG003146± 159.3
Title
Measurements
OG00049.3± 17.2
OG00138.9± 61.7
OG00271.0± 42.1
OG00350.1± 30.5
Title
Measurements
OG00088.9± 11.1
OG00139.3± 71.0
OG002126± 16.5
OG00388.1± 43.4
Title
Measurements
OG000120± 8.8
OG00120.9± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG002151± 32.4
OG003117± 43.4
Title
Measurements
OG000303± 12.4
OG001182± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG002229± 36.9
OG003308± 27.2
NA
± NA
The data was not evaluable as the samples were BLLQ.
OG004NA± NAThe data was not evaluable as the samples were BLLQ.
OG005NA± NAThe data was not evaluable as the samples were BLLQ.
OG006NA± NAThe data was not evaluable as the samples were BLLQ.
OG007NA± NAThe data was not evaluable as the samples were BLLQ.
OG008NA± NAThe data was not evaluable as the samples were BLLQ.
OG009NA± NAThe data was not evaluable as the samples were BLLQ.
OG010NA± NAThe data was not evaluable as the samples were BLLQ.
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00640
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0000.798± 404.2
OG0013.14± 29.4
OG0020.677± 6220.9
OG0032.03± 46.4
OG0041.75± 63.2
OG0054.22± 31.1
OG0061.73± 265.3
OG0073.34± 56.6
OG0082.23± 83.5
OG0093.41± 30.9
OG0103.04± 70.8
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01030
Title
Measurements
OG0002.73± 76.1
OG0016.12± 26.1
OG0027.88± 9.5
OG0035.40± 18.4
OG0045.72± 33.5
OG0058.19± 32.3
OG0065.88± 63.7
OG0076.84± 29.5
OG0082.34± 82.1
OG0098.22± 17.0
OG0105.82± 45.7
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00617
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01014
Title
Measurements
OG0000.0250± NAValues were less than reportable (LTR) for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0010.0250± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0020.0534± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0030.0250± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0040.0250± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0050.0900± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0060.110± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0072.43± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0084.71± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0091.38± 203.0
OG0101.03± 471.1
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG00620
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0107
Title
Measurements
OG0000.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0010.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0020.0906± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0030.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0040.0832± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0050.156± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0060.494± 468.8
OG0070.385± 28.6
OG0090.759± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0101.37± 93.2
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG00611
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0103
Title
Measurements
OG0000.0250± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0020.0250± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0030.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0040.0250± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0050.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0060.0294± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0070.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0080.0250± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0100.0457± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
NA
± NA
The data is not evaluable as the samples were BLLQ.
OG004NA± NAThe data is not evaluable as the samples were BLLQ.
OG005NA± NAThe data is not evaluable as the samples were BLLQ.
OG006NA± NAThe data is not evaluable as the samples were BLLQ.
OG007NA± NAThe data is not evaluable as the samples were BLLQ.
OG008NA± NAThe data is not evaluable as the samples were BLLQ.
OG009NA± NAThe data is not evaluable as the samples were BLLQ.
OG010NA± NAThe data is not evaluable as the samples were BLLQ.
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0098
ParticipantsOG01038
Title
Measurements
OG000131± 19054.2
OG001530± 22.2
OG002451± 48.0
OG003610± 3.4
OG004645± 24.6
OG005825± 20.8
OG006613± 38.2
OG007722± 25.3
OG008628± 27.1
OG009683± 22.2
OG010481± 226.7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00640
ParticipantsOG0072
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG01036
Title
Measurements
OG00019.1± 890.8
OG00157.0± 19.3
OG0029.87± 43972.4
OG00349.3± 33.6
OG00458.0± 39.7
OG00588.9± 20.7
OG00641.0± 192.1
OG00745.6± 27.7
OG00850.8± 42.6
OG00977.0± 25.3
OG01057.9± 42.2
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0006.67± 421.2
OG00122.9± 18.1
OG0024.56± 5235.8
OG00318.7± 24.2
OG00417.7± 56.9
OG00531.6± 15.3
OG00614.4± 176.9
OG00726.0± 69.8
OG00819.8± 50.5
OG00930.2± 21.5
OG01022.3± 40.6
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG01035
Title
Measurements
OG0003.69± 296.8
OG00112.6± 36.9
OG0023.25± 2446.9
OG0039.34± 44.7
OG0048.27± 62.6
OG00516.7± 40.2
OG0067.71± 209.4
OG00714.9± 66.9
OG0088.94± 100.6
OG00914.8± 29.2
OG01013.1± 45.3
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG000527± 27.3
OG001594± 18.7
OG002602± 36.8
OG003555± 3.0
OG004682± 24.0
OG005844± 19.7
OG006688± 20.7
OG007749± 23.0
OG008341± 353.1
OG009748± 17.7
OG010628± 27.6
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00637
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01030
Title
Measurements
OG00010.8± 69.4
OG00118.8± 24.9
OG00229.4± 10.1
OG00319.7± 8.2
OG00423.4± 35.0
OG00527.5± 37.0
OG00621.5± 53.3
OG00724.8± 25.8
OG0088.16± 245.5
OG00930.1± 12.3
OG01022.2± 49.8
ParticipantsOG0048
ParticipantsOG0056
ParticipantsOG00637
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01029
Title
Measurements
OG000491± 28.1
OG001587± 16.3
OG002768± 29.5
OG003620± 7.4
OG004553± 90.9
OG005474± 299.3
OG006644± 66.8
OG007968± 33.7
OG008722± 1.8
OG009775± 15.2
OG010680± 25.9
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00633
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG01024
Title
Measurements
OG00013.0± 58.5
OG0014.62± 5273.1
OG00223.5± 42.5
OG00320.5± 3.7
OG00428.6± 27.2
OG00527.3± 35.9
OG00625.2± 56.9
OG00724.3± 24.4
OG0083.73± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00931.5± 46.0
OG01024.7± 54.4
NA
± NA
The data was not evaluable as the samples were BLLQ.
OG004NA± NAThe data was not evaluable as the samples were BLLQ.
OG005NA± NAThe data was not evaluable as the samples were BLLQ.
OG006NA± NAThe data was not evaluable as the samples were BLLQ.
OG007NA± NAThe data was not evaluable as the samples were BLLQ.
OG008NA± NAThe data was not evaluable as the samples were BLLQ.
OG009NA± NAThe data was not evaluable as the samples were BLLQ.
OG010NA± NAThe data was not evaluable as the samples were BLLQ.
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00640
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0098
ParticipantsOG01038
Title
Measurements
OG0000.313± 725.2
OG0010.236± 31.1
OG0021.04± 575.7
OG0030.417± 60.3
OG0040.507± 112.0
OG005NA± NAThe data was not evaluable as the samples were BLLQ
OG0060.441± 208.3
OG0070.249± 8.7
OG0080.390± 89.0
OG0090.262± 61.9
OG0100.263± 90.8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00640
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG01036
Title
Measurements
OG0001.14± 34.8
OG00157.5± 1.46
OG0021.57± 63.6
OG0031.06± 43.6
OG0041.66± 69.9
OG0050.323± 79.3
OG0061.81± 65.3
OG0072.34± 54.7
OG0082.77± 63.1
OG0092.51± 96.3
OG0102.51± 65.1
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0000.225± 87.4
OG0010.310± 60.2
OG0020.213± 174.3
OG0030.341± 55.9
OG0040.461± 76.6
OG0052.26± 76.3
OG0060.444± 99.8
OG0070.675± 144.7
OG0080.927± 89.8
OG0090.778± 77.9
OG0100.723± 63.3
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0000.0575± 117.0
OG0010.103± 47.1
OG0020.0565± 132.5
OG0030.0982± 75.3
OG0040.0866± 141.8
OG0050.688± 73.8
OG0060.113± 136.1
OG0070.221± 199.1
OG0080.311± 76.4
OG0090.266± 161.7
OG0100.227± 66.1
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0000.152± 46.2
OG0010.184± 29.0
OG0020.399± 104.7
OG0030.175± 57.0
OG0040.231± 76.5
OG0050.150± 41.9
OG0060.257± 63.8
OG0070.343± 122.0
OG0080.564± 76.4
OG0090.407± 116.2
OG0100.322± 55.9
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00636
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01030
Title
Measurements
OG0000.131± 58.2
OG0010.106± 48.3
OG0020.180± 62.4
OG0030.172± 46.8
OG0040.155± 46.5
OG0050.263± 46.5
OG0060.167± 81.0
OG0070.238± 75.5
OG0080.459± 103.4
OG0090.295± 90.5
OG0100.220± 72.7
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00637
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01029
Title
Measurements
OG0000.235± 84.2
OG0010.163± 50.6
OG0020.255± 48.6
OG0030.270± 31.6
OG0040.209± 42.0
OG0050.206± 36.2
OG0060.260± 56.2
OG0070.331± 77.4
OG0080.565± 107.5
OG0090.364± 65.6
OG0100.311± 57.7
ParticipantsOG0048
ParticipantsOG0056
ParticipantsOG00635
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01024
Title
Measurements
OG0000.107± 73.4
OG0010.120± 62.3
OG0020.0715± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0030.239± 17.2
OG0040.189± 37.2
OG0050.289± 55.2
OG0060.162± 94.9
OG0070.197± 275.2
OG0080.795± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0090.334± 62.1
OG0100.211± 93.8
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00641
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0097
ParticipantsOG01040
Title
Measurements
OG0000.624± 94.6
OG0010.247± 162.1
OG0020.108± 53.3
OG0030.244± 149.1
OG0040.796± 86.5
OG0050.811± 310.3
OG0060.964± 69.2
OG0070.503± 47.9
OG0080.915± 47.4
OG0091.21± 103.4
OG0100.841± 94.8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01035
Title
Measurements
OG0000.336± 99.3
OG0010.347± 144.3
OG0020.453± 71.9
OG0030.943± 28.5
OG0040.298± 2853.1
OG0050.282± 498.3
OG0060.555± 1134.4
OG0070.529± 135.6
OG0080.952± 139.7
OG0090.852± 1812.3
OG0100.329± 1047.7
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0101
Title
Measurements
OG0000.532± 119.2
OG0010.306± 107.3
OG0020.351± 129.3
OG0030.822± 54.8
OG0040.769± 131.0
OG0050.921± 74.0
OG0062.69± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0070.632± 90.1
OG0081.08± 82.0
OG0091.01± 464.7
OG010NA± 5.13Since only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00639
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG01037
Title
Measurements
OG0001.12± 102.2
OG0010.572± 49.1
OG0020.548± 51.0
OG0031.31± 22.5
OG0041.65± 69.4
OG0052.04± 39.2
OG0061.99± 59.0
OG0070.830± 75.3
OG0081.49± 43.1
OG0092.03± 131.4
OG0101.50± 74.5
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0101
Title
Measurements
OG0001.38± 83.4
OG0010.933± 72.1
OG0021.21± 24.8
OG0031.99± 5.7
OG0042.15± 51.9
OG0052.55± 28.0
OG0064.82± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0070.870± 98.1
OG0081.96± 57.5
OG0092.74± 117.9
OG0105.95± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0101
Title
Measurements
OG0001.40± 74.9
OG0010.803± 76.7
OG0021.45± 32.3
OG0032.24± 18.4
OG0042.46± 59.8
OG0052.53± 32.7
OG0063.02± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0070.886± 87.6
OG0081.88± 70.8
OG0092.85± 94.7
OG0106.66± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00636
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0094
ParticipantsOG01030
Title
Measurements
OG0000.259± 157.2
OG0010.0344± 15072.4
OG0020.302± 1.2
OG0031.12± 40.2
OG0040.551± 98.4
OG0050.304± 1059.7
OG0060.561± 401.2
OG0070.0581± 1105.7
OG0080.933± 74.2
OG0090.826± 311.3
OG0100.337± 1043.6
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
Title
Measurements
OG0101.04± 8.4
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00634
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG01024
Title
Measurements
OG0000.252± 95.0
OG0010.277± 178.7
OG0020.0177± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0031.24± 56.1
OG0040.595± 95.4
OG0050.0266± 26843.8
OG0060.509± 496.6
OG0070.175± 187.9
OG0081.90± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.