A Phase Ib/II Study Investigating the Safety, Tolerabilit... | NCT03677141 | Trialant
NCT03677141
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Dec 18, 2024Actual
Enrollment
117Actual
Phase
Phase 1Phase 2
Conditions
B-cell Non-Hodgkin Lymphoma
Interventions
Mosunetuzumab
Polatuzumab Vedotin
Rituxumab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Tocilizumab
Countries
United States
Austria
France
Poland
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03677141
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO40515
Secondary IDs
ID
Type
Description
Link
2018-001039-29
EudraCT Number
Brief Title
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 8, 2019Actual
Primary Completion Date
Oct 12, 2023Actual
Completion Date
Oct 12, 2023Actual
First Submitted Date
Sep 11, 2018
First Submission Date that Met QC Criteria
Sep 17, 2018
First Posted Date
Sep 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 14, 2024
Results First Submitted that Met QC Criteria
Nov 22, 2024
Results First Posted Date
Dec 18, 2024Actual
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
Nov 22, 2024
Last Update Posted Date
Dec 18, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
Detailed Description
Not provided
Conditions Module
Conditions
B-cell Non-Hodgkin Lymphoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
117Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
Experimental
Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
Drug: Mosunetuzumab
Drug: Polatuzumab Vedotin
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Tocilizumab
Phase Ib: M-CHP-Pola Dose-Finding
Experimental
Participants will receive M-CHP-Pola up to the RP2D.
Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC)
The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria.
6-8 weeks after either C6D1 or last dose of study treatment
Secondary Outcomes
Measure
Description
Time Frame
CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II)
6-8 weeks after C6D1 or last dose of study treatment
Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II)
ORR is defined as a CR or PR at the time of primary assessment based on PET-CT, as determined by the investigator.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Phase Ib and Phase II Portions
At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter
Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
Adequate hematologic function
Inclusion Criteria for Phase Ib Portion
Participants must also meet the following criteria for study entry into the Phase Ib portion:
Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
Treatment with at least one prior CD20-directed therapy
Group B only: no prior treatment with polatuzumab vedotin
Inclusion Criteria for Phase II Portion
Participants must also meet the following criteria for study entry in the Phase II portion:
Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
International Prognostic Index (IPI) score of 2-5
Exclusion Criteria
Prior treatment with mosunetuzumab
Prior allogenic stem-cell transplant
Current Grade >1 peripheral neuropathy
Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
Prior solid organ transplantation
History of autoimmune disease
Current or past history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Significant cardiovascular disease or pulmonary disease
Clinically significant history of liver disease
Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis
Exclusion Criteria for Phase Ib Portion
Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:
Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
Prior treatment with radiotherapy within 2 weeks prior to C1D1
Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
Prior treatment with >250 mg/m^2 doxorubicin (or equivalent anthracycline dose)
Exclusion Criteria for Phase II Portion
Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:
Westin J, Phillips TJ, Mehta A, Hoffmann MS, Gonzalez-Barca E, Thieblemont C, Bastos-Oreiro M, Greil R, Giebel S, Wei MC, Wang J, Bucher R, Sit J, Penuel E, Purev E, Yee DL, Bergua-Burgues JM. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study. Blood Adv. 2025 May 27;9(10):2461-2472. doi: 10.1182/bloodadvances.2024014907.
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
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
May 27, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Tocilizumab
Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
Active Comparator
Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.
Drug: Polatuzumab Vedotin
Drug: Rituxumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone
Phase II: M-CHOP 1L DLBCL
Experimental
Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.
NOTE: No participants were enrolled to this arm.
Drug: Mosunetuzumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Tocilizumab
Phase II: M-CHP-Pola 1L DLBCL
Phase Ib: M-CHP-Pola Dose-Finding
Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
Polatuzumab Vedotin
Drug
Participants will receive polatuzumab vedotin via IV.
Phase II: M-CHP-Pola 1L DLBCL
Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
Phase Ib: M-CHP-Pola Dose-Finding
Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
Rituxumab
Drug
Participants will receive rituxumab via IV.
Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
Cyclophosphamide
Drug
Participants will receive cyclophosphamide via IV.
6-8 weeks after C6D1 or last dose of study treatment
ORR at PRA Based on CT Only as Determined by the Investigator (Phase II)
ORR is defined as a CR or PR at the time of primary assessment based on CT only, as determined by the investigator.
6-8 weeks after C6D1 or last dose of study treatment
Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II)
Best ORR was defined as CR or PR at any time on study and based on PET-CT or CT only as determined by the investigator.
Up to approximately 50 months
Duration of Response (DOR) as Determined by the Investigator (Phase II)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).
Up to approximately 50 months
Progression-free Survival (PFS) as Determined by the Investigator (Phase II)
PFS is defined as the time from randomization to the first occurrence of disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The earliest contributing event to PFS is reported. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day).
Up to approximately 50 months
PFS at 1 Year as Determined by the Investigator (Phase II)
PFS at 1 year is defined as the proportion of participants with disease progression or relapse as determined by the investigator, or death from any cause within 1 year of randomization.
1 year
Event-free Survival (EFS) as Determined by the Investigator (Phase II)
EFS is defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).
Up to 50 months
Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale
C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)
Time to Deterioration in Physical Functioning and Fatigue as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30)
C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)
Polatuzumab Vedotin Serum Concentrations
C2D1, C6D1
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D1-C6D1
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D1-C6D1
Mosunetuzumab Serum Concentrations
C1D1-C5D1
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
Cycles 1, 2, 6, 16, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
Cycles 1, 2, 6, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)
Gilbert
Arizona
85234
United States
University of California; Moores Cancer Center
La Jolla
California
92093
United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Santa Monica
California
90404-2023
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
University of Miami Miller School of Medicine
Miami
Florida
33136
United States
University of Kansas Cancer Center
Westwood
Kansas
66205
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Mayo Clinic Cancer Center
Rochester
Minnesota
55905
United States
Rhode Island Hospital
Providence
Rhode Island
02903-4923
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030-4009
United States
Scott and White Hospital; Cancer Center
Temple
Texas
76508
United States
Medical College of Wisconsin, Inc.
Milwaukee
Wisconsin
53226-3596
United States
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
Salzburg
5020
Austria
LKH Steyr
Steyr
4400
Austria
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
Vienna
1090
Austria
Hanusch-Krankenhaus
Vienna
1140
Austria
CHU Henri Mondor; Service d'Oncologie Medicale
Créteil
94010
France
Centre Leon Berard
Lyon
69008
France
Hôpital Saint-Louis
Paris
75475
France
Centre Henri Becquerel- Centre de Lutte Contre le Cancer
Saint-Herblain
44805
France
Gustave Roussy
Villejuif
94805
France
Maria Sklodowska-Curie Memorial Cancer Centre
Gliwice
44-102
Poland
Ma?opolskie Centrum Medyczne
Krakow
30-501
Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk
76-200
Poland
Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych
Warsaw
02-776
Poland
Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku
Wroc?aw
Poland
Pusan National University Yangsan Hospital
Gyeongsangnam-do
50612
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Asan Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona
Barcelona
08916
Spain
Clinica Universidad de Navarra
Pamplona
Navarre
31008
Spain
Hospital Universitario Virgen Macarena
Seville
Sevilla
41071
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
8041
Spain
Hospital San Pedro de Alcantara; Servicio de Hematología
Cáceres
10003
Spain
Hospital General Universitario Gregorio Marañon
Madrid
28007
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Derived
Olszewski AJ, Phillips TJ, Hoffmann MS, Armand P, Kim TM, Yoon DH, Mehta A, Greil R, Westin J, Lossos IS, Munoz JL, Sit J, Wei MC, Yang A, Chen V, Purev E, Yee DL, Jaeger U. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study. Blood Adv. 2023 Oct 24;7(20):6055-6065. doi: 10.1182/bloodadvances.2023010840.
FG001
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
FG002
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
FG003
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
FG004
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
FG005
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
FG0003 subjects
FG0014 subjects
FG0028 subjects
FG00340 subjects
FG00440 subjects
FG00522 subjects
COMPLETED
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG00328 subjects
FG00431 subjects
FG00519 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0027 subjects
FG00312 subjects
FG0049 subjects
FG0053 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0011 subjects
FG0026 subjects
FG0039 subjects
FG0045 subjects
FG0053 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Screen failure or enrolled in error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
BG001
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
BG002
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
BG003
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
BG004
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
BG005
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0028
BG00340
BG00440
BG00522
BG006117
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
BG00072.0± 13.0
BG00171.3± 3.4
BG00260.1± 18.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC)
The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria.
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. The primary efficacy analysis compared Arm 1 vs Arm 2, with participants grouped according to the treatment arm assigned at randomization. Group C was included in secondary efficacy analysis, and efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of participants
6-8 weeks after either C6D1 or last dose of study treatment
ID
Title
Description
OG000
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00040
OG00122
Title
Denominators
Categories
Title
Measurements
OG00072.5(56.11 to 85.40)
OG00177.3(54.63 to 92.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in rates
-4.77
2-Sided
95
-30.61
21.07
Superiority
Secondary
CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II)
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of participants
6-8 weeks after C6D1 or last dose of study treatment
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II)
ORR is defined as a CR or PR at the time of primary assessment based on PET-CT, as determined by the investigator.
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of participants
6-8 weeks after C6D1 or last dose of study treatment
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Secondary
ORR at PRA Based on CT Only as Determined by the Investigator (Phase II)
ORR is defined as a CR or PR at the time of primary assessment based on CT only, as determined by the investigator.
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of participants
6-8 weeks after C6D1 or last dose of study treatment
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Secondary
Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II)
Best ORR was defined as CR or PR at any time on study and based on PET-CT or CT only as determined by the investigator.
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of responders
Up to approximately 50 months
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Duration of Response (DOR) as Determined by the Investigator (Phase II)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).
The number of participants analyzed was the number of participants with a PR or CR in each arm. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Median
Full Range
Months
Up to approximately 50 months
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Progression-free Survival (PFS) as Determined by the Investigator (Phase II)
PFS is defined as the time from randomization to the first occurrence of disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The earliest contributing event to PFS is reported. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day).
Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day).
Posted
Median
Full Range
Months
Up to approximately 50 months
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
PFS at 1 Year as Determined by the Investigator (Phase II)
PFS at 1 year is defined as the proportion of participants with disease progression or relapse as determined by the investigator, or death from any cause within 1 year of randomization.
Efficacy analyses for Arms A1, A2, and B were exploratory.
Posted
Number
95% Confidence Interval
Percentage of participants
1 year
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Event-free Survival (EFS) as Determined by the Investigator (Phase II)
EFS is defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).
Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment or documentation of NALT were censored at the date of randomization or first study treatment, plus 1 day).
Posted
Median
Full Range
Months
Up to 50 months
ID
Title
Description
OG000
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol.
Posted
Median
95% Confidence Interval
Months
C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)
ID
Title
Description
OG000
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
Secondary
Time to Deterioration in Physical Functioning and Fatigue as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30)
The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol.
Posted
Median
95% Confidence Interval
Months
C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)
ID
Title
Description
OG000
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
Secondary
Polatuzumab Vedotin Serum Concentrations
Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
C2D1, C6D1
ID
Title
Description
OG000
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
C1D1-C6D1
ID
Title
Description
OG000
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
C1D1-C6D1
ID
Title
Description
OG000
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Mosunetuzumab Serum Concentrations
Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive mosunetuzumab were not included in this endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
C1D1-C5D1
ID
Title
Description
OG000
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG001
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
OG002
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Secondary
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants.
Posted
Number
Number of participants
Cycles 1, 2, 6, 16, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)
ID
Title
Description
OG000
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Secondary
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants.
Posted
Number
Number of participants
Cycles 1, 2, 6, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)
ID
Title
Description
OG000
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG001
Time Frame
Up to approximately 30 months.
Description
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
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
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
2
3
3
3
3
3
EG001
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
1
4
4
4
4
4
EG002
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
6
8
6
8
8
8
EG003
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
9
40
20
40
40
40
EG004
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
5
40
24
38
38
38
EG005
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
3
22
3
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected8 at risk
EG0031 events1 affected40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Chest pain
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Death
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Fatigue
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral swelling
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Ulcer
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Congestive hepatopathy
Hepatobiliary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected8 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Fungal oesophagitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Septic shock
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Anastomotic leak
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Troponin I increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Central nervous system lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Ageusia
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected8 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0023 events3 affected8 at risk
EG003
Horner's syndrome
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected8 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected8 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Pallor
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected8 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00040
OG00140
OG00222
Title
Denominators
Categories
Title
Measurements
OG00087.5(73.20 to 95.81)
OG00180.0(64.35 to 90.95)
OG00277.3(54.63 to 92.18)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00040
OG00140
OG00222
Title
Denominators
Categories
Title
Measurements
OG00085.0(70.16 to 94.29)
OG00172.5(56.11 to 85.40)
OG00281.8(59.72 to 94.81)
Units
Counts
Participants
OG00040
OG00136
OG00222
Title
Denominators
Categories
Title
Measurements
OG00095.0(83.08 to 99.39)
OG00185.0(70.16 to 94.29)
OG00295.5(77.16 to 99.88)
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00038
OG00134
OG00221
Title
Denominators
Categories
Title
Measurements
OG000NA(0 to 28)This value could not be determined due to an insufficient number of participants with the event.
OG001NA(0 to 28)This value could not be determined due to an insufficient number of participants with the event.
OG002NA(1 to 27)This value could not be determined due to an insufficient number of participants with the event.
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00040
OG00140
OG00222
Title
Denominators
Categories
Title
Measurements
OG000NA(0 to 31)This value could not be determined due to an insufficient number of participants with the event.
OG001NA(0 to 30)This value could not be determined due to an insufficient number of participants with the event.
OG002NA(3 to 30)This value could not be determined due to an insufficient number of participants with the event.
Units
Counts
Participants
OG00040
OG00140
OG00222
Title
Denominators
Categories
Title
Measurements
OG00077.47(63.65 to 91.29)
OG00170.83(55.59 to 86.07)
OG00281.82(65.70 to 97.94)
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG00012
OG00111
OG0025
Title
Denominators
Categories
Title
Measurements
OG000NA(2 to 31)This value could not be determined due to an insufficient number of participants with the event.
OG001NA(0 to 30)This value could not be determined due to an insufficient number of participants with the event.
OG002NA(3 to 30)This value could not be determined due to an insufficient number of participants with the event.
OG00040
OG00122
Title
Denominators
Categories
Title
Measurements
OG000NA(2.3 to NA)Value was not estimable due to an insufficient number of participants with the event.
OG0016.5(2.1 to NA)Value was not estimable due to an insufficient number of participants with the event.
OG00040
OG00122
Title
Denominators
Categories
Title
Measurements
OG0002.3(1.2 to 5.4)
OG0012.3(0.8 to NA)Value was not estimable due to an insufficient number of participants with the event.
Units
Counts
Participants
OG0008
OG00140
OG00222
Title
Denominators
Categories
C2D1 pre-dose
ParticipantsOG0006
ParticipantsOG00133
ParticipantsOG00218
Title
Measurements
OG0000.993± 779.4
OG0011.99± 80.7
OG0021.73± 107.9
C6D1 pre-dose
ParticipantsOG0004
ParticipantsOG00127
ParticipantsOG00220
Title
Measurements
OG000
Units
Counts
Participants
OG0008
OG00140
OG00222
Title
Denominators
Categories
C1D1 post-dose
ParticipantsOG0008
ParticipantsOG00122
ParticipantsOG00216
Title
Measurements
OG000620± 54.5
OG001668± 21.2
OG002584± 23.1
C1D2 pre-dose
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
C1D2 24hrs post-dose
ParticipantsOG0008
ParticipantsOG00124
ParticipantsOG0020
Title
Measurements
OG000
C1D8 pre-dose
ParticipantsOG0007
ParticipantsOG00129
ParticipantsOG0020
Title
Measurements
OG000
C1D15 pre-dose
ParticipantsOG0007
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C2D1 pre-dose
ParticipantsOG0006
ParticipantsOG00131
ParticipantsOG00218
Title
Measurements
OG000
C2D1 post-dose
ParticipantsOG0006
ParticipantsOG00132
ParticipantsOG00213
Title
Measurements
OG000
C3D1 pre-dose
ParticipantsOG0005
ParticipantsOG00133
ParticipantsOG0020
Title
Measurements
OG000
C3D1 post-dose
ParticipantsOG0005
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C4D1 pre-dose
ParticipantsOG0004
ParticipantsOG00133
ParticipantsOG00221
Title
Measurements
OG000
C4D1 post-dose
ParticipantsOG0004
ParticipantsOG00130
ParticipantsOG00218
Title
Measurements
OG000
C5D1 pre-dose
ParticipantsOG0003
ParticipantsOG00129
ParticipantsOG0020
Title
Measurements
OG000
C5D1 post-dose
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG0020
Title
Measurements
OG000
C6D1 pre-dose
ParticipantsOG0004
ParticipantsOG00125
ParticipantsOG00219
Title
Measurements
OG000
Units
Counts
Participants
OG0008
OG00140
OG00222
Title
Denominators
Categories
C1D1 post-dose
ParticipantsOG0008
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG0000.535± 464.6
OG0010.55± 71.1
OG0020.432± 78.8
C1D2 pre-dose
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
C1D2 24hrs post-dose
ParticipantsOG0008
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C1D8 pre-dose
ParticipantsOG0007
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C1D15 pre-dose
ParticipantsOG0007
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C2D1 pre-dose
ParticipantsOG0006
ParticipantsOG00133
ParticipantsOG00218
Title
Measurements
OG000
C2D1 post-dose
ParticipantsOG0006
ParticipantsOG00135
ParticipantsOG00214
Title
Measurements
OG000
C3D1 pre-dose
ParticipantsOG0005
ParticipantsOG00133
ParticipantsOG0020
Title
Measurements
OG000
C3D1 post-dose
ParticipantsOG0005
ParticipantsOG00132
ParticipantsOG0020
Title
Measurements
OG000
C4D1 pre-dose
ParticipantsOG0004
ParticipantsOG00133
ParticipantsOG00221
Title
Measurements
OG000
C4D1 post-dose
ParticipantsOG0004
ParticipantsOG00130
ParticipantsOG00218
Title
Measurements
OG000
C5D1 pre-dose
ParticipantsOG0003
ParticipantsOG00130
ParticipantsOG0020
Title
Measurements
OG000
C5D1 post-dose
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0020
Title
Measurements
OG000
C6D1 pre-dose
ParticipantsOG0004
ParticipantsOG00127
ParticipantsOG00219
Title
Measurements
OG000
OG003
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG004
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG0003
OG0014
OG0028
OG00340
OG00440
Title
Denominators
Categories
C1D1 post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG00337
ParticipantsOG00422
Title
Measurements
OG0000.157± 22.1
OG0010.181± 26.7
OG0030.155± 34.1
OG004
C1D1 2 hrs post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG00335
C1D2 2 hrs post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
C1D2 24 hrs post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG00336
C1D8 pre-dose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG00339
C1D8 post-dose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG00339
C1D8 2hrs post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG00338
C1D15 pre-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG00339
C1D15 post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG00339
C1D15 2 hrs post-dose
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG00338
C2D1 pre-dose
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG00337
C2D1 post-dose
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG00335
C2D1 2 hrs post-dose
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00334
C2D2 pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C2D2 post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C3D1 pre-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG00333
C3D1 post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG00334
C4D1 pre-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00332
C4D1 post-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00332
C5D1 pre-dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG00330
OG001
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
OG002
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG003
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
OG004
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG0003
OG0014
OG0028
OG00340
OG00438
Title
Denominators
Categories
Positive sample at baseline
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG00338
ParticipantsOG00433
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not positive at baseline
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG00338
Positive for treatment-emergent ADA
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00339
Positive for treatment-induced ADA
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00339
Positive for treatment-enhanced ADA
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00339
Negative for treatment-emergent ADA
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00339
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
OG002
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Units
Counts
Participants
OG0008
OG00138
OG00222
Title
Denominators
Categories
Positive sample at baseline
ParticipantsOG0008
ParticipantsOG00138
ParticipantsOG00221
Title
Measurements
OG0000
OG0011
OG0022
Not positive at baseline
ParticipantsOG0008
ParticipantsOG00138
ParticipantsOG00221
Title
Measurements
OG000
Positive for treatment-emergent ADA
ParticipantsOG0006
ParticipantsOG00137
ParticipantsOG00221
Title
Measurements
OG000
Positive for treatment-induced ADA
ParticipantsOG0006
ParticipantsOG00137
ParticipantsOG00221
Title
Measurements
OG000
Positive for treatment-enhanced ADA
ParticipantsOG0006
ParticipantsOG00137
ParticipantsOG00221
Title
Measurements
OG000
Negative for treatment-emergent ADA
ParticipantsOG0006
ParticipantsOG00137
ParticipantsOG00221
Title
Measurements
OG000
7 events
6 affected
40 at risk
EG0045 events5 affected38 at risk
EG0053 events1 affected22 at risk
3 events
3 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0043 events3 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0045 events5 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0047 events3 affected38 at risk
EG0052 events1 affected22 at risk
30 events
19 affected
40 at risk
EG00424 events14 affected38 at risk
EG00511 events7 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
6 events
5 affected
40 at risk
EG00410 events6 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
6 events
5 affected
40 at risk
EG0043 events3 affected38 at risk
EG0052 events2 affected22 at risk
0 events
0 affected
40 at risk
EG0043 events2 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
9 events
8 affected
40 at risk
EG0046 events6 affected38 at risk
EG0051 events1 affected22 at risk
4 events
4 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
17 events
14 affected
40 at risk
EG0046 events6 affected38 at risk
EG0054 events4 affected22 at risk
14 events
12 affected
40 at risk
EG00417 events12 affected38 at risk
EG0056 events4 affected22 at risk
7 events
6 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
3 events
2 affected
40 at risk
EG0047 events6 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
33 events
22 affected
40 at risk
EG00424 events17 affected38 at risk
EG00510 events9 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
9 events
6 affected
40 at risk
EG0043 events3 affected38 at risk
EG0052 events2 affected22 at risk
18 events
11 affected
40 at risk
EG00411 events9 affected38 at risk
EG0057 events5 affected22 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected38 at risk
EG0051 events1 affected22 at risk
3 events
3 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0052 events2 affected22 at risk
5 events
5 affected
40 at risk
EG0042 events1 affected38 at risk
EG0051 events1 affected22 at risk
23 events
19 affected
40 at risk
EG00413 events12 affected38 at risk
EG00513 events10 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
9 events
8 affected
40 at risk
EG0047 events5 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0051 events1 affected22 at risk
13 events
8 affected
40 at risk
EG0044 events4 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
30 events
24 affected
40 at risk
EG00427 events22 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
4 events
4 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0052 events2 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
2 events
1 affected
40 at risk
EG0044 events3 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG00410 events9 affected38 at risk
EG0053 events2 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
8 events
6 affected
40 at risk
EG00410 events10 affected38 at risk
EG0054 events4 affected22 at risk
7 events
5 affected
40 at risk
EG0046 events6 affected38 at risk
EG0053 events3 affected22 at risk
4 events
3 affected
40 at risk
EG0041 events1 affected38 at risk
EG0053 events3 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
3 events
2 affected
40 at risk
EG0042 events1 affected38 at risk
EG0056 events2 affected22 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0053 events3 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
19 events
4 affected
40 at risk
EG0043 events1 affected38 at risk
EG0058 events3 affected22 at risk
13 events
8 affected
40 at risk
EG00418 events11 affected38 at risk
EG0057 events5 affected22 at risk
12 events
5 affected
40 at risk
EG0048 events4 affected38 at risk
EG0054 events3 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
4 events
4 affected
40 at risk
EG0044 events4 affected38 at risk
EG0051 events1 affected22 at risk
10 events
3 affected
40 at risk
EG00412 events6 affected38 at risk
EG0057 events3 affected22 at risk
17 events
15 affected
40 at risk
EG00413 events11 affected38 at risk
EG0051 events1 affected22 at risk
4 events
4 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
5 events
4 affected
40 at risk
EG0043 events2 affected38 at risk
EG0054 events3 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
14 events
6 affected
40 at risk
EG0044 events2 affected38 at risk
EG0051 events1 affected22 at risk
8 events
6 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
25 events
13 affected
40 at risk
EG0044 events4 affected38 at risk
EG0051 events1 affected22 at risk
6 events
6 affected
40 at risk
EG0045 events4 affected38 at risk
EG0050 events0 affected22 at risk
9 events
2 affected
40 at risk
EG0043 events3 affected38 at risk
EG0052 events2 affected22 at risk
12 events
7 affected
40 at risk
EG0046 events4 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
3 events
3 affected
40 at risk
EG0042 events2 affected38 at risk
EG0052 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
3 events
3 affected
40 at risk
EG0045 events5 affected38 at risk
EG0053 events3 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0053 events2 affected22 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
4 events
4 affected
40 at risk
EG0041 events1 affected38 at risk
EG0053 events3 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0052 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
9 events
9 affected
40 at risk
EG0046 events6 affected38 at risk
EG0050 events0 affected22 at risk
7 events
7 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
14 events
9 affected
40 at risk
EG0042 events2 affected38 at risk
EG0058 events7 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
13 events
13 affected
40 at risk
EG0043 events3 affected38 at risk
EG0055 events4 affected22 at risk
3 events
1 affected
40 at risk
EG0042 events2 affected38 at risk
EG0052 events2 affected22 at risk
3 events
1 affected
40 at risk
EG0046 events5 affected38 at risk
EG0054 events4 affected22 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
6 events
6 affected
40 at risk
EG0042 events2 affected38 at risk
EG0056 events6 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected38 at risk
EG0052 events2 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
9 events
7 affected
40 at risk
EG0040 events0 affected38 at risk
EG0053 events3 affected22 at risk
7 events
7 affected
40 at risk
EG0044 events4 affected38 at risk
EG0053 events3 affected22 at risk
3 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0053 events2 affected22 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
2 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0043 events2 affected38 at risk
EG0052 events2 affected22 at risk
12 events
12 affected
40 at risk
EG0047 events7 affected38 at risk
EG0059 events9 affected22 at risk
3 events
2 affected
40 at risk
EG0041 events1 affected38 at risk
EG0051 events1 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
2 affected
40 at risk
EG0044 events4 affected38 at risk
EG0051 events1 affected22 at risk
5 events
4 affected
40 at risk
EG0048 events6 affected38 at risk
EG0054 events4 affected22 at risk
2 events
2 affected
40 at risk
EG0042 events2 affected38 at risk
EG0051 events1 affected22 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
2 events
1 affected
40 at risk
EG0041 events1 affected38 at risk
EG0050 events0 affected22 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0045 events2 affected38 at risk
EG0051 events1 affected22 at risk
13 events
9 affected
40 at risk
EG0042 events2 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0050 events0 affected22 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected38 at risk
EG0051 events1 affected22 at risk
2.76
± 820.1
OG0018.13± 34.5
OG0025.8± 42
219
± 412.2
115
± 658.3
OG001275± 28.2
23
± 1040.4
OG00142± 82
8.22
± 550.4
OG00113.2± 87.4
4.87
± 626
OG0016.81± 80.1
OG0027.09± 95.5
656
± 21.1
OG001653± 18
OG002654± 21
19.2
± 58.7
OG00115.8± 39.5
144
± 112947.3
OG001544± 90.7
16.8
± 79.6
OG00116.8± 50.3
OG00215.6± 41.4
783
± 26.5
OG001614± 15.4
OG002696± 24.1
7.14
± 343.5
OG00119± 39.7
544
± 37.6
OG001605± 21.6
11.8
± 476.6
OG00121.2± 34.7
OG00217.3± 40.8
1.94
± 114.2
3.3
± 97.8
OG0012.82± 51.9
2.95
± 80.9
OG0011.27± 93.6
0.604
± 113.3
OG0010.301± 104.1
0.187
± 47.3
OG0010.0773± 110.2
OG0020.0697± 87
0.238
± 64
OG0010.137± 84
OG0020.116± 56.3
0.168
± 92
OG0010.146± 96.9
0.111
± 173.9
OG0010.203± 92.7
0.0491
± NA
If more than one-third of values were lower than reportable, only the median, maximum, and geometric mean are reported.