A Study of Polatuzumab Vedotin in Combination With Rituxi... | NCT01992653 | Trialant
NCT01992653
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Mar 14, 2023Actual
Enrollment
85Actual
Phase
Phase 1Phase 2
Conditions
Lymphoma, Non Hodgkin
Interventions
Cyclophosphamide
Doxorubicin
Obinutuzumab
Polatuzumab Vedotin
Prednisolone
Prednisone
Rituximab
Countries
United States
France
Protocol Section
Identification Module
NCT ID
NCT01992653
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO29044
Secondary IDs
ID
Type
Description
Link
2013-003541-42
EudraCT Number
Brief Title
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
Official Title
A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 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
Nov 29, 2013Actual
Primary Completion Date
Dec 19, 2018Actual
Completion Date
Dec 19, 2018Actual
First Submitted Date
Oct 28, 2013
First Submission Date that Met QC Criteria
Nov 19, 2013
First Posted Date
Nov 25, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2019
Results First Submitted that Met QC Criteria
Feb 18, 2020
Results First Posted Date
Mar 3, 2020Actual
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
Mar 10, 2023
Last Update Posted Date
Mar 14, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.
Detailed Description
Not provided
Conditions Module
Conditions
Lymphoma, Non Hodgkin
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
85Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Polatuzumab Vedotin (1.4mg) + G-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Polatuzumab Vedotin (1.0mg) + R-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Polatuzumab Vedotin (1.8mg) + G-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Polatuzumab Vedotin (1.4mg) + R-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Drug: Cyclophosphamide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cyclophosphamide
Drug
Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Baseline up to 5 years
Number of Participants With Adverse Events in Non-DLBCL Population
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Baseline up to 5 years
Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All Participants:
At least one bi-dimensionally measurable lesion, defined as greater than (>) 1.5 centimeters (cm) in its longest dimension
Life expectancy of at least 24 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Adequate hematologic function (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator)
Agreement to use highly effective contraception measures. Women of childbearing potential must agree to remain abstinent or use contraceptive measures that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 12 months for R-CHP arm or for at least 18 months for G-CHP arm after the last dose of study drug. Men must agree to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of study drug
Dose-Escalation Portion of the Study:
Histologically confirmed B-cell NHL: Participants with newly diagnosed B-cell NHL or relapsed/refractory B-cell NHL are eligible
No more than one prior systemic treatment regimen for B-cell NHL (single agent anti-cluster of differentiation [CD] 20 monoclonal antibody therapy will not be counted as a prior treatment regimen)
No prior treatment with anthracyclines
Expansion Portion of the Study:
Previously untreated participants with diffuse large B-cell lymphoma (DLBCL)
International Prognostic Index (IPI) score of 2-5
Exclusion Criteria:
Dose-Escalation Portion of the Study:
Diagnosis of primary mediastinal DLBCL
Expansion Portion of the Study:
Participants with transformed lymphoma
Prior therapy for NHL
All Participants:
Prior stem cell transplant
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to receive any of the individual components of R-CHP or G-CHP
Current Grade greater than (>) 1 peripheral neuropathy
Ongoing corticosteroid use of >30 milligrams per day (mg/day) of prednisone/prednisolone or equivalent. Participants receiving corticosteroid treatment with less than or equal to (\
Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.
A total of 85 participants were enrolled at 11 centers in the following countries: France (31 participants) and United States (54 participants). 3 participants did not receive any study treatment (2 had exclusionary lab values and 1 withdrew) meaning that the safety population consisted of 82 participants.
Recruitment Details
The study was conducted at 11 centers in 2 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
FG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Jul 26, 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
Drug: Doxorubicin
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Polatuzumab Vedotin (1.8mg) + R-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Polatuzumab Vedotin (2.4mg) + R-CHP
Experimental
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Experimental
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Experimental
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
Doxorubicin
Drug
Doxorubicin will be administered at 50 mg/m^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
Obinutuzumab
Drug
Obinutuzumab will be administered at 1000 milligrams (mg) IV on Cycle 1 Days 1, 8, and 15 and on Day 1 of Cycles 3-8.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Gazyva/Gazyvaro
Polatuzumab Vedotin
Drug
Polatuzumab vedotin will be administered at escalating doses (at a starting dose of 1 mg/kg) IV every 3 weeks, for 6 or 8 cycles.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
DCDS4501A
Prednisolone
Drug
Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
Prednisone
Drug
Prednisone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + G-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + G-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
Rituximab
Drug
Rituximab will be administered at 375 mg/m^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (1.0mg) + R-CHP
Polatuzumab Vedotin (1.4mg) + R-CHP
Polatuzumab Vedotin (1.8mg) + R-CHP
Polatuzumab Vedotin (2.4mg) + R-CHP
MabThera/Rituxan
Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
Number of Participants With DLTs in Non-DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
At the end of treatment (Month 6)
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
At the end of treatment (Month 6)
Number of Participants With Anti-Polatuzumab Vedotin Antibodies
The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL.
Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)
Number of Participants With Anti-Obinutuzumab Antibodies
The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA.
Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)
Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Maximum Concentration (Cmax) of Polatuzumab Vedotin
Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Clearance (CL) of Polatuzumab Vedotin
CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Terminal Half-Life (t1/2) of Polatuzumab Vedotin
t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Plasma Levels of Cyclophosphamide
Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)
Plasma Levels of Doxorubicin
Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
6 months
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
6 months
Overall Survival for DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
Screening up to death due to any cause (up to approximately 6 years)
Overall Survival for Non-DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
Screening up to death due to any cause (up to approximately 6 years)
Greeley
Colorado
85234
United States
Washington University; Pediatrics
St Louis
Missouri
63110
United States
Northwest Cancer Specialists
Portland
Oregon
97210
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Willamette Valley Clinical Studies; Cancer Institute
Springfield
Oregon
97477
United States
Blue Ridge Cancer Care
Roanoke
Virginia
24014
United States
Hopital Henri Mondor, Unite Hemopathies lymphoides
Créteil
94010
France
Hopital Claude Huriez - CHU Lille; Service des maladies du sang
Lille
59037
France
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite
69495
France
Centre Henri Becquerel; Hematologie
Rouen
76038
France
Derived
Tilly H, Morschhauser F, Bartlett NL, Mehta A, Salles G, Haioun C, Munoz J, Chen AI, Kolibaba K, Lu D, Yan M, Penuel E, Hirata J, Lee C, Sharman JP. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study. Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
FG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
FG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
FG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
FG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
FG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
FG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0031 subjects
FG0046 subjects
FG0056 subjects
FG00640 subjects
FG00717 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0025 subjects
FG0031 subjects
FG0045 subjects
FG0056 subjects
FG00632 subjects
FG00713 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0068 subjects
FG0074 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0064 subjects
FG0072 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Completed
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
BG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
BG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
BG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
BG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
BG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
BG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
BG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
BG0031
BG0046
BG0056
BG00640
BG00717
BG00882
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
BG00067.3± 6.4
BG00165.0± 7.0
BG00267.3± 3.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0013
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Not Hispanic or Latino
Title
Measurements
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
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
Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Count of Participants
Participants
Baseline up to 5 years
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0025
OG003
Primary
Number of Participants With Adverse Events in Non-DLBCL Population
An adverse event is 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 adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Count of Participants
Participants
Baseline up to 5 years
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Count of Participants
Participants
Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Primary
Number of Participants With DLTs in Non-DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Count of Participants
Participants
Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Number
90% Confidence Interval
Percentage of Participants
At the end of treatment (Month 6)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Number
90% Confidence Interval
Percentage of Participants
At the end of treatment (Month 6)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Number of Participants With Anti-Polatuzumab Vedotin Antibodies
The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Count of Participants
Participants
Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Number of Participants With Anti-Obinutuzumab Antibodies
The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Count of Participants
Participants
Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Mean
Standard Deviation
ng day/mL
Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Maximum Concentration (Cmax) of Polatuzumab Vedotin
Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Mean
Standard Deviation
ng/mL
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Clearance (CL) of Polatuzumab Vedotin
CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Mean
Standard Deviation
mL/day/kg
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Terminal Half-Life (t1/2) of Polatuzumab Vedotin
t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Mean
Standard Deviation
days
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Posted
Mean
Standard Deviation
mL/kg
Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Plasma Levels of Cyclophosphamide
Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of cyclophosphamide were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Posted
Mean
Standard Deviation
ug/mL
End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Plasma Levels of Doxorubicin
Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of doxorubicin were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Posted
Mean
Standard Deviation
ug/mL
2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Posted
Mean
Standard Deviation
Score of a Questionnaire
Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Posted
Mean
Standard Deviation
Score of a Questionnaire
Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Secondary
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Mean
Standard Deviation
Percentage
6 months
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Mean
Standard Deviation
Percentage
6 months
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Secondary
Overall Survival for DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to death due to any cause (up to approximately 6 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Secondary
Overall Survival for Non-DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Posted
Median
95% Confidence Interval
Months
Screening up to death due to any cause (up to approximately 6 years)
ID
Title
Description
OG000
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Time Frame
5 years
Description
The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
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
Polatuzumab Vedotin (1.0mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
0
3
1
3
3
3
EG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
0
3
1
3
3
3
EG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
1
6
4
6
6
6
EG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
0
1
0
1
1
1
EG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
1
6
1
6
6
6
EG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
0
6
3
6
6
6
EG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
4
40
15
40
40
40
EG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
2
17
6
17
17
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected6 at risk
EG0053 events2 affected6 at risk
EG0064 events3 affected40 at risk
EG0074 events4 affected17 at risk
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected6 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ASTHENIA
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ESCHERICHIA URINARY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ORAL FUNGAL INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PELVIC FRACTURE
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
INFLUENZA A VIRUS TEST POSITIVE
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CHYLOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected1 at risk
EG0044 events3 affected6 at risk
EG0055 events2 affected6 at risk
EG00624 events14 affected40 at risk
EG0077 events3 affected17 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0028 events4 affected6 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
CERUMEN IMPACTION
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
EAR DISCOMFORT
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
EXCESSIVE CERUMEN PRODUCTION
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOACUSIS
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MIDDLE EAR EFFUSION
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
AMBLYOPIA
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
CATARACT
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CONJUNCTIVAL HYPERAEMIA
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CONJUNCTIVAL IRRITATION
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DIPLOPIA
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
EYE IRRITATION
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
COLITIS MICROSCOPIC
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0027 events5 affected6 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ERUCTATION
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
GASTROINTESTINAL MOTILITY DISORDER
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERCHLORHYDRIA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events3 affected3 at risk
EG0027 events4 affected6 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ASTHENIA
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CHEST PAIN
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CHILLS
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
DEVICE RELATED THROMBOSIS
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
FATIGUE
General disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0014 events3 affected3 at risk
EG0023 events3 affected6 at risk
EG003
FEELING HOT
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ILL-DEFINED DISORDER
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
OEDEMA
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PAIN
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PYREXIA
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CONJUNCTIVITIS VIRAL
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ESCHERICHIA URINARY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
OPHTHALMIC HERPES ZOSTER
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SUBCUTANEOUS ABSCESS
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
MEDICATION ERROR
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
POST LUMBAR PUNCTURE SYNDROME
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PROCEDURAL HEADACHE
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD LACTIC ACID INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD PHOSPHORUS DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
STAPHYLOCOCCUS TEST POSITIVE
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
STREPTOCOCCUS TEST POSITIVE
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
TROPONIN I INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
TROPONIN INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
SYNOVIAL CYST
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
BALANCE DISORDER
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events2 affected3 at risk
EG0022 events2 affected6 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
DYSTONIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ENCEPHALOPATHY
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected6 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOGEUSIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PERIPHERAL SENSORIMOTOR NEUROPATHY
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
TREMOR
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
AFFECT LABILITY
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected6 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
MOOD ALTERED
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NIGHTMARE
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
URINE FLOW DECREASED
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
TESTICULAR OEDEMA
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ATELECTASIS
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
LOWER RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
TACHYPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
THROAT IRRITATION
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
THROAT TIGHTNESS
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
NAIL RIDGING
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
PAPULE
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
PHLEBITIS
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 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.
Due to there being only 1 participant in this group, the SD could not be estimated.
BG00470.7± 4.5
BG00560.0± 14.3
BG00669.6± 7.2
BG00761.6± 14.6
BG00866.9± 9.9
4
BG0030
BG0042
BG0054
BG00620
BG0076
BG00839
Male
BG0003
BG0010
BG0022
BG0031
BG0044
BG0052
BG00620
BG00711
BG00843
6
BG0031
BG0046
BG0056
BG00627
BG00714
BG00866
Not Stated
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0069
BG0073
BG00812
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0064
BG0070
BG0084
0
BG0030
BG0041
BG0050
BG0060
BG0071
BG0082
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0064
BG0071
BG0085
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0063
BG0070
BG0083
White
Title
Measurements
BG0003
BG0013
BG0026
BG0031
BG0045
BG0056
BG00633
BG00715
BG00872
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
0
OG0044
OG0054
OG00640
OG00717
0
OG0044
OG0054
OG00640
OG00717
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0070
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG00050.0(2.53 to 97.47)
OG001100.0(36.84 to 100.00)
OG002100.0(54.93 to 100.00)
OG00475.0(24.86 to 98.73)
OG005100.0(47.29 to 100.0)
OG00675.0(61.29 to 85.76)
OG00776.5(53.95 to 91.54)
Partial Response (PR)
Title
Measurements
OG00050.0(2.53 to 97.47)
OG0010(0.00 to 63.16)
OG0020(0.00 to 45.07)
OG004
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG000100.0(5.00 to 100.00)
OG002100.0(5.00 to 100.00)
OG003100.0(5.00 to 100.00)
OG004100.0(22.36 to 100.00)
OG005100.0(22.36 to 100.0)
Partial Response (PR)
Title
Measurements
OG0000(0.00 to 95.00)
OG0020(0.00 to 95.00)
OG0030(0.00 to 95.00)
OG004
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG0001300± 22
OG0011510± 354
OG0022600± 413
OG0034090± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG0041940± 154
OG0051850± 491
OG0061870± 527
OG0071940± 482
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000373± 147
OG001537± 184
OG002781± 72.6
OG0031400± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG004537± 59.1
OG005557± 114
OG006532± 163
OG007530± 138
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG00014.0± 0.370
OG00117.3± 4.16
OG00212.8± 2.05
OG00310.5± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG00413.2± 1.29
OG00518.7± 5.30
OG00618.9± 5.27
OG00717.7± 3.83
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG0005.03± 0.905
OG0014.85± 0.720
OG0024.79± 0.675
OG0034.42± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG0045.19± 0.430
OG0054.89± 0.526
OG0065.03± 0.621
OG0075.50± 0.795
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0031
OG0046
OG0056
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG00058.2± 9.92
OG00180.0± 9.97
OG00257.7± 7.95
OG00341.9± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG00467.9± 7.42
OG00587.5± 19.3
OG00696.5± 34.1
OG00799.3± 27.4
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00640
OG00717
Title
Denominators
Categories
C1D1 0.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00622
ParticipantsOG00713
Title
Measurements
OG00637.5± 24.4
OG00732.3± 7.64
C1D1 3.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D1 23.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 0.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 3.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 23.5hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00640
OG00717
Title
Denominators
Categories
C1D1 2hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00623
ParticipantsOG00711
Title
Measurements
OG00635.4± 13.6
OG00730.2± 6.82
C1D1 24hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 2hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 24hr POSTDOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00640
OG00717
Title
Denominators
Categories
Baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG0060± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG0070.32± 0.45
Week 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 10
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 11
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 13
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 19
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 20
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 21
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Polatuzumab Vedotin (1.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG002
Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00640
OG00717
Title
Denominators
Categories
Baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG0060± NADue to there being only 1 participant in this group, the SD could not be estimated.
OG0070± 0
Week 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 10
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 11
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 13
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 19
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 20
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 21
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG001NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG002NA(14.03 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG006NA(27.93 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG007NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG0024.11(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG003NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG001NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG002NA(17.02 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(7.79 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG006NA(30.62 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG007NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG0026.87(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG003NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG001NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG002NA(17.02 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(3.42 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(5.88 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG00635.45(28.32 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG007NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG0026.87(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG0036.70(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000100.70± 0.99
OG00199.97± 0.55
OG00296.04± 4.81
OG00499.35± 3.19
OG00599.95± 0.75
OG00696.71± 6.99
OG00798.92± 3.74
OG003
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000100.00± NAMedian, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG002100.94± NAMedian, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG003132.22± NAMedian, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG00499.72± 0.06
OG005100.17± 0.14
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG0030
OG0044
OG0054
OG00640
OG00717
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG001NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG002NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(7.79 to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG006NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG007NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Polatuzumab Vedotin (2.4mg) + R-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
OG004
Polatuzumab Vedotin (1.4mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG005
Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
OG006
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
OG007
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0031
OG0042
OG0052
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG00215.24(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG003NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG004NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
OG005NA(NA to NA)Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0069 events6 affected40 at risk
EG0074 events3 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG00616 events7 affected40 at risk
EG0072 events2 affected17 at risk
0 events
0 affected
1 at risk
EG0043 events3 affected6 at risk
EG0055 events5 affected6 at risk
EG00622 events13 affected40 at risk
EG0079 events6 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0043 events1 affected6 at risk
EG0052 events1 affected6 at risk
EG00616 events6 affected40 at risk
EG0076 events6 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected40 at risk
EG0073 events2 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected40 at risk
EG0072 events2 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected6 at risk
EG0064 events3 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
1 events
1 affected
1 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected6 at risk
EG00614 events11 affected40 at risk
EG0075 events5 affected17 at risk
1 events
1 affected
1 at risk
EG0044 events2 affected6 at risk
EG0052 events2 affected6 at risk
EG00625 events17 affected40 at risk
EG00714 events11 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0071 events1 affected17 at risk
1 events
1 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected40 at risk
EG0072 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0072 events2 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
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EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected40 at risk
EG0072 events2 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected6 at risk
EG0062 events2 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
1 events
1 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected17 at risk
1 events
1 affected
1 at risk
EG0041 events1 affected6 at risk
EG0053 events3 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
1 events
1 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0 events
0 affected
1 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG00616 events7 affected40 at risk
EG0072 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected40 at risk
EG0071 events1 affected17 at risk
0 events
0 affected
1 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected17 at risk
0
(0.00 to 52.71)
OG0050(0.00 to 52.71)
OG00615.0(6.74 to 27.47)
OG00711.8(2.13 to 32.62)
0
(0.00 to 77.64)
OG0050(0.00 to 77.64)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00621
ParticipantsOG00713
Title
Measurements
OG00623.2± 2.38
OG00722.5± 3.69
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00625
ParticipantsOG00714
Title
Measurements
OG0062.98± 1.39
OG0073.32± 1.50
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00628
ParticipantsOG00715
Title
Measurements
OG00634.8± 6.14
OG00735.2± 13.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00629
ParticipantsOG00716
Title
Measurements
OG00624.2± 3.87
OG00722.5± 4.26
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00619
ParticipantsOG00714
Title
Measurements
OG0063.17± 1.66
OG0073.16± 1.68
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00625
ParticipantsOG00712
Title
Measurements
OG0069.13± 2.51
OG00711.7± 11.6
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00627
ParticipantsOG00716
Title
Measurements
OG00629.3± 10.9
OG00729.6± 10.8
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00620
ParticipantsOG00714
Title
Measurements
OG0068.68± 2.05
OG0079.14± 2.12
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0073
Title
Measurements
OG0060± 0
OG0070.91± 0.92
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG0060.02± 0.04
OG0070.07± 0.16
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG0060.06± 0.10
OG0070.22± 0.44
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0076
Title
Measurements
OG0060.18± 0.36
OG0070.26± 0.63
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0076
Title
Measurements
OG0060.16± 0.32
OG0070.17± 0.41
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0075
Title
Measurements
OG0060.16± 0.32
OG0070.25± 0.57
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0075
Title
Measurements
OG0060.14± 0.28
OG0070.35± 0.77
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0066
ParticipantsOG0078
Title
Measurements
OG0060.17± 0.37
OG0070.31± 0.59
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0078
Title
Measurements
OG0060.25± 0.47
OG0070.38± 0.61
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0060.30± 0.41
OG0070.53± 0.71
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0060.26± 0.35
OG0070.39± 0.73
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0060.30± 0.43
OG0070.65± 1.02
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG0060.25± 0.32
OG0070.78± 1.34
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0068
ParticipantsOG0078
Title
Measurements
OG0060.49± 0.86
OG0070.62± 1.05
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0068
ParticipantsOG0078
Title
Measurements
OG0060.48± 0.86
OG0070.70± 1.28
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0078
Title
Measurements
OG0060.66± 0.94
OG0071.12± 1.61
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0077
Title
Measurements
OG0060.25± 0.52
OG0070.91± 1.44
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0070.64± NADue to there being only 1 participant in this group, the SD could not be estimated.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0070.45± NADue to there being only 1 participant in this group, the SD could not be estimated.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0070.09± NADue to there being only 1 participant in this group, the SD could not be estimated.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0073
Title
Measurements
OG0060± 0
OG0071± 1.73
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG0060.25± 0.50
OG0070± 0
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG0060.33± 0.58
OG0070.40± 0.89
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0076
Title
Measurements
OG0060.40± 0.55
OG0070.50± 1.22
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0076
Title
Measurements
OG0060.40± 0.55
OG0070.17± 0.41
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0075
Title
Measurements
OG0060.40± 0.55
OG0070.40± 0.89
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0075
Title
Measurements
OG0060.29± 0.49
OG0070.60± 1.34
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0066
ParticipantsOG0078
Title
Measurements
OG0060.33± 0.52
OG0070.25± 0.71
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0078
Title
Measurements
OG0060.40± 0.55
OG0070.50± 1.07
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0060.86± 1.21
OG0071.14± 1.46
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0060.86± 1.21
OG0070.57± 1.13
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0061.14± 1.21
OG0070.71± 1.25
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG0060.86± 1.21
OG0071.12± 1.81
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0068
ParticipantsOG0078
Title
Measurements
OG0061.12± 1.73
OG0070.88± 1.36
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0068
ParticipantsOG0078
Title
Measurements
OG0061.12± 1.73
OG0070.75± 1.16
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0078
Title
Measurements
OG0061.56± 2.07
OG0071.50± 1.69
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG0077
Title
Measurements
OG0060.40± 0.55
OG0071.14± 1.46
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0072± NADue to there being only 1 participant in this group, the SD could not be estimated.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0072± NADue to there being only 1 participant in this group, the SD could not be estimated.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0071± NADue to there being only 1 participant in this group, the SD could not be estimated.