Trial of Magrolimab (Hu5F9-G4) in Combination With Rituxi... | NCT02953509 | Trialant
NCT02953509
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
May 29, 2025Actual
Enrollment
178Actual
Phase
Phase 1Phase 2
Conditions
Non Hodgkin Lymphoma
Interventions
Magrolimab
Rituximab
Gemcitabine
Oxaliplatin
Allopurinol
Countries
United States
Australia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02953509
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5F9003
Secondary IDs
ID
Type
Description
Link
2016-003408-29
EudraCT Number
Brief Title
Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Official Title
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated early due to the magrolimab program discontinuation.
Expanded Access Info
No
Start Date
Nov 21, 2016Actual
Primary Completion Date
Mar 25, 2024Actual
Completion Date
Mar 25, 2024Actual
First Submitted Date
Nov 1, 2016
First Submission Date that Met QC Criteria
Nov 1, 2016
First Posted Date
Nov 2, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 25, 2025
Results First Submitted that Met QC Criteria
May 12, 2025
Results First Posted Date
May 29, 2025Actual
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
May 12, 2025
Last Update Posted Date
May 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Name
Class
The Leukemia and Lymphoma Society
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
The primary objectives of this study are:
To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.
Participants with B-cell non-hodgkin's lymphoma (NHL) will receive 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Up to 28 days
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Up to 28 days
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
Secondary Outcomes
Measure
Description
Time Frame
PK Parameter of Magrolimab: AUClast
AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies
DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing cluster of differentiation (CD) 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy
Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment
Adequate performance status and hematological, liver and kidney functions
Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2018 Nov 1;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.
Participants with B-cell non-hodgkin's lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Autologous stem cell transplant ineligible diffuse large B-cell lymphoma (DLBCL) participants will receive 1 mg/kg magrolimab IV infusion priming dose(over 3 hours)on Day 1 of Cycle 1,followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1;Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles.Cycle length will be 28 days.Rituximab 375 mg/m^2 IV infusion will be given on Days 8, 15, 22, and 29 of Cycle 1,followed by 1 dose on Day 1 of Cycles 2 to 6.Thereafter from Cycle 8 and beyond,rituximab will be administered on Day 1 of every other cycle(on even cycles).Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be given as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.Granulocyte colony stimulating factor (G-CSF) prophylaxis will be given with gemcitabine and oxaliplatin treatment(Cycles 1-4).Allopurinol 300 mg orally daily will be administered for the first cycle only.
Autologous stem cell transplant ineligible DLBCL participants will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length of 28 days. Rituximab 375 mg/m^2 IV infusion will be administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis will be administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily will be administered for the first cycle only.
Drug: Magrolimab
Drug: Rituximab
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Allopurinol
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Experimental
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma [FL] and marginal zone lymphoma [MZL]) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Drug: Magrolimab
Drug: Rituximab
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Experimental
Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Drug: Magrolimab
Drug: Rituximab
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Experimental
Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Drug: Magrolimab
Drug: Rituximab
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Experimental
Participants with DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each Cycle length of 28 days.
Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas
ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline & residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% length beyond normal; no new sites.
Up to 7.3 years
PK Parameter of Magrolimab: AUCtau
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
PK Parameter of Magrolimab: Cmax
Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)
Up to 4 years
Duration of Response (DOR)
DOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease[progressive metabolic disease(PMD);progressive radiologic disease(PRD)]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi >1.5 cm;≥ 50% increase from cross product of LDi & perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 & 1 cm for lesions >2 cm;spleen increased by >50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.
Up to 7.3 years
Progression Free Survival (PFS)
PFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease & not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi & PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 & 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.
Up to 7.3 years
Overall Survival (OS)
OS is measured from dose initiation until death.
Up to 7.3 years
Time to Progression (TTP)
TTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.
Up to 7.3 years
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas
Objective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR[CMR;CRR] or PR[PMR;PRR].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% in length beyond normal;no new sites.
Up to 7.3 years
Duarte
California
91010
United States
Stanford Cancer Center
Stanford
California
94305
United States
Georgia Cancer Center at Augusta University
Augusta
Georgia
30912
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
National Institutes of Health Clinical Center/ National Cancer Institute
Bethesda
Maryland
20892
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
University of Minnesota Medical Center, Fairview
Minneapolis
Minnesota
55455
United States
Washington University School of Medicine Siteman Cancer Center
St Louis
Missouri
63110
United States
Levine Cancer Institute
Charlotte
North Carolina
28204
United States
Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
The Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Princess Alexandra Hospital
Brisbane
Queensland
4102
Australia
St. Vincent's Hospital Melbourne
Melbourne
Victoria
3065
Australia
Linear Clinical Research Ltd
Nedlands
Western Australia
6009
Australia
The Churchill Hospital
Oxford
OX3 7LE
United Kingdom
Background
Advani R, Volkmer JP, Chao MP. CD47 Blockade and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2019 Jan 31;380(5):497-498. doi: 10.1056/NEJMc1816156. No abstract available.
Background
Mehta A, Popplewell L, Collins GP, Smith S, Flinn I, Bartlett NL, et al. Magrolimab in Combination With Rituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: 3-Year Follow-up Results From a Phase 1/2 Trial. Am J Hematol 2022;97:S3-S40.
Background
Maakaron J, Asch AS, Popplewell LL, Collins GP, Flinn IW, Ghosh N, et al. Magrolimab in Combination with Rituximab + Chemotherapy in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Blood 2022;140 (Supplement 1):3728-3730.
Background
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. Activity of thefirst-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
Background
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 + rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
Background
Roschewski M, Advani R, Bartlett NL, Smith SM, Popplewell L, Flinn I, et al. Activity of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
Background
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
Background
Wang B, Jin D, Cho MM, Takimoto C, Chao M, Agoram B. Magrolimab (Hu5F9-G4, 5F9) Treatment Does Not Alter Rituximab Pharmacokinetics in Patients With Non-Hodgkin's Lymphoma [Poster THU-008]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Background
Wang B, Jin D, Takimoto C, Chao M, Agoram B. Magrolimab Treatment Does Not Alter Rituximab Pharmacokinetics in Patients with Non-Hodgkin's Lymphoma [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Background
Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population-Pharmacokinetics of Magrolimab (Hu5F9-G4, 5F9) in Patients With Solid Tumors and Lymphomas [Poster TUE-020]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Background
Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population pharmacokinetics of magrolimab (5F9, Hu5F9-G4) in patients with solid tumors and lymphomas [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Maakaron JE, Asch A, Popplewell L, Collins GP, Flinn IW, Ghosh N, Keane C, Ku M, Mehta A, Roschewski M, Hacohen-Kleiman G, Huo Y, Zhang Y, Renard C, Smith SM, Advani R. Magrolimab plus rituximab with or without chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2024 Nov 26;8(22):5864-5874. doi: 10.1182/bloodadvances.2024013338.
Mehta A, Popplewell L, Collins GP, Smith SM, Flinn IW, Bartlett NL, Ghosh N, Hacohen-Kleiman G, Huo Y, Su-Feher L, Renard C, Advani R, Roschewski M. Magrolimab plus rituximab in relapsed/refractory indolent non-Hodgkin lymphoma: 3-year follow-up of a phase 1/2 trial. Blood Adv. 2024 Nov 26;8(22):5855-5863. doi: 10.1182/bloodadvances.2024013277.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
Autologous stem cell transplant (or transplantation) ineligible diffuse large B-cell lymphoma (DLBCL) participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. Granulocyte colony stimulating factor (G-CSF) prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
FG006
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma [FL] and marginal zone lymphoma [MZL]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
FG007
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
FG008
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
FG009
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
BG006
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
BG007
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
BG008
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
BG009
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
BG010
Total~(N=178)
Denominators
Units
Counts
Participants
BG0003
BG0016
BG00213
BG0037
BG00426
BG0057
BG00643
BG00714
BG00831
BG00928
BG010178
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058± 12.8
BG00160± 11.3
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
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
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0016
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
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
The DLT Analysis Set 1 (Antibody Combination) included all enrolled Phase 1b participants in the magrolimab + rituximab cohort who met either of the following criteria:
The participant experienced a DLT
The participants completed at least 3 infusions of magrolimab and 2 infusions of rituximab.
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
Units
Counts
Participants
OG0003
OG0016
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG00116.7
OG00215.4
OG003
Primary
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
The DLT Analysis Set 2 (Chemotherapy Combination)included all enrolled Phase 1b participants in the magrolimab + rituximab, gemcitabine,and oxaliplatin (R-GemOx) cohort who met either of the following criteria in DLT assessment period:
Participants had DLT at any time after initiation of first infusion of magrolimab, rituximab, and gemcitabine or oxaliplatin
Participants completed at least 3 infusions of magrolimab, 2 infusions of rituximab, and 1 infusion of gemcitabine and oxaliplatin
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
The Safety Analysis Set included all participants who received at least 1 dose of any study treatment.
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas
ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline & residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% length beyond normal; no new sites.
The Efficacy Analysis Set included all enrolled participants who received at least 1 dose of magrolimab. As prespecified in the statistical analysis plan (SAP), the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Secondary
PK Parameter of Magrolimab: AUClast
AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
The Pharmacokinetics (PK) Analysis Set included all participants who received at least 1 dose of study drug and had measurable concentrations of magrolimab from PK blood samples. Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Posted
Mean
Standard Deviation
day*micrograms(μg)/milliliters(mL)
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Secondary
PK Parameter of Magrolimab: AUCtau
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Posted
Mean
Standard Deviation
day*μg/mL
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Posted
Mean
Standard Deviation
μg/mL
Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Secondary
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)
The ADA analysis set included participants with at least one reported ADA result where participants evaluable for ADA incidence were defined as participants with non-missing baseline sample and at least one sample taken after drug administration during the treatment or follow-up observation period that are appropriate for ADA testing (with reportable result). As prespecified in SAP,ADA results were to be reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Secondary
Duration of Response (DOR)
DOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease[progressive metabolic disease(PMD);progressive radiologic disease(PRD)]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi >1.5 cm;≥ 50% increase from cross product of LDi & perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 & 1 cm for lesions >2 cm;spleen increased by >50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.
Participants in the Efficacy Analysis Set with an objective response (CR + PR) and those who had objective response without a subsequent event of disease progression/death were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Median
95% Confidence Interval
months
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Secondary
Progression Free Survival (PFS)
PFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease & not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi & PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 & 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.
Participants in the efficacy analysis set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Median
95% Confidence Interval
months
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG001
Secondary
Overall Survival (OS)
OS is measured from dose initiation until death.
Participants in the Efficacy Analysis Set with available were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Median
95% Confidence Interval
months
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG001
Magrolimab 10 mg/kg + Rituximab (iNHL)
All IL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Secondary
Time to Progression (TTP)
TTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.
Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Median
95% Confidence Interval
months
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG001
Secondary
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas
Objective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR[CMR;CRR] or PR[PMR;PRR].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% in length beyond normal;no new sites.
Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 7.3 years
ID
Title
Description
OG000
Magrolimab 10 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Time Frame
Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Description
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug.
All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
3
7
5
7
7
7
EG006
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
26
43
19
43
42
43
EG007
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
10
14
9
14
14
14
EG008
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
22
31
21
31
31
31
EG009
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
21
28
11
28
27
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG0030 affected7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0064 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0091 affected28 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Gastric varices haemorrhage
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Malignant ascites
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Retroperitoneal mass
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Asthenia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Chills
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Death, not otherwise specified
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Disease progression
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Device related infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0023 affected13 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Septic shock
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Wound infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Chest wall haematoma
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Device dislocation
Product Issues
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0020 affected13 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected6 at risk
EG0025 affected13 at risk
EG0030 affected7 at risk
EG00420 affected26 at risk
EG0053 affected7 at risk
EG00615 affected43 at risk
EG0074 affected14 at risk
EG00810 affected31 at risk
EG00911 affected28 at risk
Haemolysis
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected6 at risk
EG0022 affected13 at risk
EG003
Red blood cell agglutination
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0023 affected13 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Blindness
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Diplopia
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Dry eye
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Iritis
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Photophobia
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Vision blurred
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected6 at risk
EG0028 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected6 at risk
EG0027 affected13 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0020 affected13 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0025 affected13 at risk
EG003
Asthenia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Catheter site bruise
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Catheter site erythema
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Catheter site pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Catheter site pruritus
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Catheter site rash
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Catheter site related reaction
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Catheter site vesicles
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Chest discomfort
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Chest pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Chills
General disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0014 affected6 at risk
EG0025 affected13 at risk
EG003
Facial pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Fatigue
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0015 affected6 at risk
EG0029 affected13 at risk
EG003
Feeling hot
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Gait disturbance
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Generalised oedema
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Influenza like illness
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Infusion site swelling
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Malaise
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Oedema
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Peripheral swelling
General disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0013 affected6 at risk
EG0025 affected13 at risk
EG003
Temperature intolerance
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Body tinea
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Candida infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Ear infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Infected bite
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Otitis media
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Paronychia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Septic shock
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Skin infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0025 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected6 at risk
EG0027 affected13 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Body temperature increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Cd4 lymphocytes decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Haptoglobin decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Heart rate increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Immunoglobulins decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0024 affected13 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Total lung capacity decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0026 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected6 at risk
EG0023 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0027 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected6 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Anosmia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Cerebral microangiopathy
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Cranial nerve paralysis
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected6 at risk
EG0022 affected13 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected6 at risk
EG0029 affected13 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0023 affected13 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tremor
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Vibratory sense increased
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Device occlusion
Product Issues
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Depression
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Procedural anxiety
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0015 affected6 at risk
EG0026 affected13 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected6 at risk
EG0023 affected13 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Dyspnoea paroxysmal nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected6 at risk
EG0020 affected13 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pharyngeal swelling
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected6 at risk
EG0022 affected13 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected13 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Purpura senile
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected13 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected13 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected13 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Flushing
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Hot flush
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected13 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected13 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected13 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
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Autologous stem cell transplant (or transplantation) ineligible diffuse large B-cell lymphoma (DLBCL) participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG00116.7
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
OG006
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma [FL] and marginal zone lymphoma [MZL]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
OG007
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
OG008
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
OG009
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
Units
Counts
Participants
OG0003
OG0016
OG00213
OG0037
OG00426
OG0057
OG00643
OG00714
OG00831
OG00928
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG00496.2
OG005100.0
OG00697.7
OG007100.0
OG008100.0
OG009100.0
OG001
Magrolimab 10 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG003
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8,15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
OG013
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Units
Counts
Participants
OG0003
OG0015
OG00214
OG0038
OG00418
OG0057
OG00618
OG00724
OG00814
OG0092
OG01015
OG01112
OG0121
OG0138
Title
Denominators
Categories
Day 1 (Cycle 1, Day 1)
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG00214
ParticipantsOG0030
ParticipantsOG00418
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG00713
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG001NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
Day 8 (Cycle 1, Day 8)
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG00214
ParticipantsOG0038
Day 29 (Cycle 2, Day 1)
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG00214
ParticipantsOG0038
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and marginal zone lymphoma MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
OG013
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Units
Counts
Participants
OG0003
OG0015
OG00214
OG0038
OG00418
OG0057
OG00618
OG00724
OG00814
OG0092
OG01015
OG01112
OG0121
OG0138
Title
Denominators
Categories
Day 1 (Cycle 1, Day 1)
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG00214
ParticipantsOG0030
ParticipantsOG00418
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG00713
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG001NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
OG013
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Units
Counts
Participants
OG0003
OG0015
OG00214
OG0038
OG00418
OG0057
OG00618
OG00724
OG00814
OG0092
OG01015
OG01112
OG0121
OG0138
Title
Denominators
Categories
Day 1 (Cycle 1, Day 1)
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG00214
ParticipantsOG0030
ParticipantsOG00418
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG00713
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG0000.619± NAStandard deviation cannot be calculated for 1 participant.
OG0011.32± 1.31
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8,15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1, Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine, and oxaliplatin IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
OG013
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
Units
Counts
Participants
OG0003
OG0016
OG00214
OG0037
OG00415
OG0056
OG00617
OG00724
OG00813
OG0092
OG01011
OG0113
OG0121
OG0133
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046.7
OG0050
OG0060
OG0070
OG0087.7
OG0090
OG0100
OG0110
OG0120
OG0130
OG001
Magrolimab 10 mg/kg + Rituximab (iNHL):
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG003
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Units
Counts
Participants
OG0000
OG0011
OG0023
OG0030
OG00414
OG00518
OG0066
OG0075
OG00812
OG0095
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)The median, lower, and upper limit of 95% confidence interval (CI) were not estimable due to insufficient number of events.
OG002NA(3.9 to NA)The median and upper limit of 95% CI were not estimable due to insufficient number of events.
OG0045.5(3.5 to 22.3)
OG00515.9(5.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG00621.2(1.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG00711.3(3.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG008NA(2.0 to NA)The median and upper limit of 95% CI were not estimable due to insufficient number of events.
OG00918.0(4.7 to NA)The upper limit of 95% CI were not estimable due to insufficient number of events.
Magrolimab 10 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG003
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Units
Counts
Participants
OG0002
OG0011
OG0026
OG0030
OG00468
OG00530
OG00623
OG00715
OG00826
OG0097
Title
Denominators
Categories
Title
Measurements
OG0001.6(1.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG001NA(NA to NA)The median, lower, and upper limit of 95% CI was not estimable due to insufficient number of events.
OG0025.6(1.2 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG0041.8(1.6 to 2.1)
OG0057.5(5.5 to 23.9)
OG0062.1(1.6 to 3.6)
OG0075.5(1.8 to 13.0)
OG0083.9(2.3 to 11.1)
OG00920.3(0.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG003
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Units
Counts
Participants
OG0002
OG0011
OG0026
OG0030
OG00468
OG00530
OG00623
OG00715
OG00826
OG0097
Title
Denominators
Categories
Title
Measurements
OG00013.9(NA to NA)The lower and upper limit of 95% CI were not estimable due to insufficient number of events.
OG001NA(NA to NA)The median, lower and upper limit of 9,5% CI were not estimable due to insufficient number of events.
OG00232.2(2.3 to NA)The upper-limit of 95% CI were not estimable due to insufficient number of events.
OG0048.5(5.8 to 11.3)
OG005NA(62.9 to NA)The median and upper-limit of 95% CI were not estimable due to insufficient number of events.
OG00614.0(3.4 to 17.4)
OG00723.7(3.8 to NA)The upper-limit of 95% CI were not estimable due to insufficient number of events.
OG00841.4(6.1 to NA)The upper-limit of 95% CI were not estimable due to insufficient number of events.
OG009NA(0.5 to NA)The median and upper-limit of 95% CI were not estimable due to insufficient number of events.
Magrolimab 10 mg/kg + Rituximab (iNHL)
All IL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG003
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Units
Counts
Participants
OG0002
OG0011
OG0026
OG0030
OG00468
OG00530
OG00623
OG00715
OG00826
OG0097
Title
Denominators
Categories
Title
Measurements
OG0001.6(1.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG001NA(NA to NA)The median, lower, and upper limit of 95% CI was not estimable due to insufficient number of events.
OG0025.6(1.2 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG0041.8(1.7 to 2.1)
OG0057.9(5.5 to 23.9)
OG0062.0(1.6 to 4.3)
OG0075.6(1.8 to 13.0)
OG0083.9(2.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG00920.3(6.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of events.
OG001
Magrolimab 10 mg/kg + Rituximab (iNHL)
All IL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 10 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG002
Magrolimab 20 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG003
Magrolimab 20 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 20 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG004
Magrolimab 30 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG005
Magrolimab 30 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 30 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG006
Magrolimab 45 mg/kg + Rituximab (DLBCL)
All DLBCL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
OG007
Magrolimab 45 mg/kg + Rituximab (iNHL)
All iNHL participants in Phases 1b and 2, antibody combination arms who received a maintenance dose of 45 mg/kg magrolimab IV infusion in combination with rituximab 375 mg/m^2 IV infusion.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
Units
Counts
Participants
OG0002
OG0011
OG0026
OG0030
OG00468
OG00530
OG00623
OG00715
OG00826
OG0097
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG0010(0.0 to 97.5)
OG00250.0(11.8 to 88.2)
OG00422.1(12.9 to 33.8)
OG00560.0(40.6 to 77.3)
OG00626.1(10.2 to 48.4)
OG00733.3(11.8 to 61.6)
OG00846.2(26.6 to 66.6)
OG00971.4(29.0 to 96.3)
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0071 affected14 at risk
EG0081 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0043 affected26 at risk
EG0051 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
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EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0051 affected7 at risk
EG0064 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0072 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0081 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0045 affected26 at risk
EG0054 affected7 at risk
EG00617 affected43 at risk
EG0070 affected14 at risk
EG0088 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
2 affected
7 at risk
EG0048 affected26 at risk
EG0054 affected7 at risk
EG00613 affected43 at risk
EG0073 affected14 at risk
EG00810 affected31 at risk
EG0098 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0084 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0043 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0092 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0051 affected7 at risk
EG0062 affected43 at risk
EG0073 affected14 at risk
EG0084 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0063 affected43 at risk
EG0071 affected14 at risk
EG0086 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0043 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0071 affected14 at risk
EG0081 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0065 affected43 at risk
EG0072 affected14 at risk
EG0082 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0084 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0065 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0043 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0052 affected7 at risk
EG0064 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0052 affected7 at risk
EG0063 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
3 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0068 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0092 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0066 affected43 at risk
EG0071 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0064 affected43 at risk
EG0072 affected14 at risk
EG0081 affected31 at risk
EG0091 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0081 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
1 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0061 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0062 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0051 affected7 at risk
EG0061 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0041 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0082 affected31 at risk
EG0090 affected28 at risk
1 affected
7 at risk
EG0046 affected26 at risk
EG0053 affected7 at risk
EG0066 affected43 at risk
EG0072 affected14 at risk
EG0084 affected31 at risk
EG0095 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0071 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0042 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0091 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0090 affected28 at risk
0 affected
7 at risk
EG0040 affected26 at risk
EG0050 affected7 at risk
EG0060 affected43 at risk
EG0070 affected14 at risk
EG0080 affected31 at risk
EG0092 affected28 at risk
OG004
NA
± NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG006NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG007NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0057
ParticipantsOG00614
ParticipantsOG00720
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01015
ParticipantsOG01112
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000770± 346
OG0011810± 426
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG003NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG005NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0062300± 280
OG0072220± 877
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG010NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG011NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0057
ParticipantsOG00618
ParticipantsOG00724
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01015
ParticipantsOG01112
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG0001470± 431
OG0014260± 1050
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG003NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG005NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG006NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG007NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG010NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG011NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG004
NA
± NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG006NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG007NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0057
ParticipantsOG00614
ParticipantsOG00720
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01015
ParticipantsOG01112
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000671± NAStandard deviation cannot be calculated for 1 participant.
OG0011810± 426
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG003NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG005NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0062300± 280
OG0072080± 658
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG010NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG011NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0057
ParticipantsOG00618
ParticipantsOG00724
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01015
ParticipantsOG01112
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG0001220± 97.0
OG0014260± 1050
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG003NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG005NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG006NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG007NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG010NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG011NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
NA
± NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0060.477± 0.178
OG0070.496± 0.353
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0057
ParticipantsOG00614
ParticipantsOG00720
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01011
ParticipantsOG0119
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000212± 54.6
OG001485± 114
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG003924± 170
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG005906± 160
OG006567± 75.7
OG007542± 188
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG010918± 251
OG011904± 414
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
ParticipantsOG00418
ParticipantsOG0055
ParticipantsOG00618
ParticipantsOG00724
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0121
ParticipantsOG0138
Title
Measurements
OG000330± 123
OG001903± 186
OG002NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0031862± 411
OG004NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0052096± 449
OG006NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG007NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG008NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG009NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG0101858± 321
OG0112186± 615
OG012NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
OG013NA± NAData could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.