Flotetuzumab in Primary Induction Failure (PIF) or Early... | NCT02152956 | Trialant
NCT02152956
Sponsor
MacroGenics
Status
Terminated
Last Update Posted
Jan 30, 2024Actual
Enrollment
244Actual
Phase
Phase 1Phase 2
Conditions
AML
Interventions
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
Ruxolitinib
Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
Countries
United States
France
Germany
Israel
Italy
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02152956
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CP-MGD006-01
Secondary IDs
Not provided
Brief Title
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Official Title
A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)
Acronym
VOYAGE
Organization
MacroGenicsINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business decision
Expanded Access Info
YesNCT04678466No longer available
Start Date
Jun 9, 2014Actual
Primary Completion Date
Jul 5, 2022Actual
Completion Date
Jul 5, 2022Actual
First Submitted Date
May 28, 2014
First Submission Date that Met QC Criteria
May 28, 2014
First Posted Date
Jun 2, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 5, 2023
Results First Submitted that Met QC Criteria
Jan 24, 2024
Results First Posted Date
Jan 30, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 24, 2024
Last Update Posted Date
Jan 30, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MacroGenicsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.
Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.
Detailed Description
Not provided
Conditions Module
Conditions
AML
Keywords
AML
leukemia
myelogenous
myeloid
refractory
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
244Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 0-a
Experimental
Biological: Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
Cohort 0-b
Experimental
Biological: Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Cohort 0-c
Experimental
Biological: Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Cohort 0-d
Experimental
Biological: Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Cohort 1
Experimental
Biological: Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Cohort 2
Experimental
Biological: Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Cohort 2a
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
Cohort 0-a
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy Based on CR or CRh Rate
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], molecular CR [CRm], or CRh per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
up to 14 months
Secondary Outcomes
Measure
Description
Time Frame
Overall Complete Response Rate
Rate of CR + CRh + CRi (CR with incomplete blood cell recovery [CR with incomplete neutrophil {CRn}or platelet recovery {CRp}]) + MLFS (morphologic leukemia-free state)
up to 14 months
CR Rate
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification
Patients with AML must meet one of the following criteria, a or b:
Primary Induction Failure (PIF) AML, defined as disease refractory to either, i or ii:
i. An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens. Examples include but are not limited to: 1 cycle of high dose cytarabine (HiDAC) containing regimen, 1 cycle of liposomal cytarabine and daunorubicin, 2 cycles of standard dose cytarabine containing regimen
ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens: i ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine, or ii ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy
Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months
Limit of 3 prior lines of therapy (excluding focal radiation therapy for palliative purposes): up to 2 induction (induction, re-induction) or 1 induction plus/minus 1 consolidation attempt, followed by a maximum of 1 salvage/re-induction attempt.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy of at least 4 weeks
Peripheral blast count </= 20,000/mm3 at the time of first dose
Acceptable laboratory parameters and adequate organ reserve
Exclusion Criteria:
History of allogeneic stem cell transplantation
Prior treatment with an anti-CD123-directed agent
Need for concurrent other cytoreductive chemotherapy
Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1.
Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution
Use of immunosuppressant medications in the 2 weeks prior to Cycle 1 Day 1
Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to Cycle 1 Day 1
Known central nervous system (CNS) leukemia
Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection),
Known human immunodeficiency virus infection, unless all of the following criteria are met: CD4+ count ≥ 350 cells/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
Known, active, history of or current acute or chronic hepatitis B or C virus (HBV) infection (as evidenced by detectable HBV surface antigen and HBV DNA ≥ 500 IU/mL),
History of hepatitis C virus (HCV) infection, unless the infection has been treated and cured,
Active SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing for ongoing infection should follow local clinical practice guidelines/standards. Participants with a positive test result for ongoing SARS-CoV-2 infection, known asymptomatic infection, or suspected infection are excluded unless or until asymptomatic and with subsequent negative SARS-CoV-2 laboratory test.
Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Recher C, Stiff PJ, Pettit KM, Lowenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
FG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 26, 2021
Apr 27, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 3
Experimental
Biological: Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
Cohort 6
Experimental
Biological: Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 7
Experimental
Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 8
Experimental
Biological: Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
MTD Expansion
Experimental
Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
MTD expansion with Ruxolitinib
Experimental
Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Drug: Ruxolitinib
MGD006
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 0-b
MGD006
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 0-c
MGD006
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 0-d
MGD006
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 1
MGD006
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
Cohort 2
MGD006
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 2a
Cohort 7
MTD Expansion
MTD expansion with Ruxolitinib
MGD006
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 3
MGD006
Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 8
MGD006
Ruxolitinib
Drug
Oral inhibitor of JAK kinase
MTD expansion with Ruxolitinib
Jakafi
Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
Biological
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
Cohort 6
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], or molecular CR [CRm] per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
up to 14 months
CRh Rate
Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.
CRh is defined as: CR with partial hematologic recovery.
up to 14 months
Overall Response Rate
Proportion of patients achieving a best response of CR, CRh, CRi, MLFS or partial response per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
up to 14 months
HSCT Rate
Rate of successful hematopoietic stem cell transplantation (HSCT) after the start flotetuzumab treatment and before subsequent therapy.
up to 8 months
Occurrence of Dose Limiting Toxicity
Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is < 33% during the first cycle of MGD006 treatment.
Cycle 1 of a 28 day cycle.
Occurrence of Adverse Events (AEs)
Cycle 1 through end of treatment
up to 9 months
Occurrence of Serious Adverse Events (SAEs)
up to 9 months
Participants With Anti-drug Antibodies
Occurrence of anti-drug antibody
Study Day 1, then every 28 days through 28-days after the last dose (up to 8 months)
Number of Patients With Infusion Related Reaction (IRR)
Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS
During study drug administration (up to 8 months)
Number of Patients With Cytokine Release Syndrome (CRS)
up to 9 months
Maximum Serum Concentration of Flotetuzumab
Measure the pharmacokinetics (PK) of flotetuzumab
Study day 1, then every 28 days and 28 days after the last dose (up to 8 months)
Post-baseline Transfusion Independence Rate
The number of patients who were transfusion-dependent at baseline and did not receive transfusions during any consecutive 56-day period will be calculated. The number of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.
56 days
Number of Patients Alive at 6 Months
6 months
Event-free Survival
Time from the first dose of study drug until date of evidence of primary refractory disease to flotetuzumab, relapse from CR, CRh or CRi, or death from any cause, whichever occurs first.
Up to 2 years
Mortality Rate
number of deaths from any cause within 30, 60, 90, or 180 days of first dose of study drug
Throughout the study, up to 3 years.
Number of Patients Alive at 12 Months
Number of patients alive at 1 year from first dose of study drug
1 year
Median Time to Response
Time from first dose of study drug to first CR, CRh, CRi, or MLFS
up to 14 months
Duration of Response of Patients With CR or CRh
Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.
Up to 2 years
Overall Survival
Time from first dose to death from any cause
Up to 2 years
Rate of Hospitalization for Patients in the Expansion Cohort After Initial Discharge
Initial dosing procedures were performed as a hospital inpatient. Incidence rate of hospitalization after discharge from the hospital will be calculated
up to 8 months
Duration of Hospitalization for Patients in the Expansion Cohort
Duration of hospitalization will be characterized after discharge from initial dosing will be characterized
up to 8 months
La Jolla
California
92093
United States
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco
California
94115
United States
University of California, San Francisco
San Francisco
California
94143
United States
Georgetown University - Lombardi Cancer Center
Washington D.C.
District of Columbia
20057
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Emory University
Atlanta
Georgia
30322
United States
Loyola University Chicago - Cardinal Bernadin Cancer Center
Maywood
Illinois
60153
United States
University of Maryland
Baltimore
Maryland
21201
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Stony Brook Medicine
Stony Brook
New York
11794
United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill
North Carolina
27599
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Providence Portland Medical Center
Portland
Oregon
97213
United States
Vanderbilt-Ingram Cancer Center
Nashville
Tennessee
37232
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Institut Paoli-Calmettes
Marseille
13002
France
Centre Hospitalier Universitaire de Nantes
Nantes
44093
France
Institut Universitaire du Cancer de Toulouse-Oncopole
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden
01307
Germany
Universitätsklinik Hamburg-Eppendorf
Hamburg
20246
Germany
Universitätsklinikum Leipzig
Leipzig
04103
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
55131
Germany
III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München
Munich
81675
Germany
Medizinische Klinik und II, Universitätsklinikum Würzburg
Würzbur
97080
Germany
Rambam Health Care Campus
Haifa
Israel
Shaare Zedek Medical Center
Jerusalem
Israel
Policlinico Sant'Orsola Malpighi
Bologna
40138
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
74014
Italy
University Vita-Salute San Raffaele
Milan
20132
Italy
Unità Operativa di Ematologia Ospedale Santa Maria delle Croci
Ravenna
48123
Italy
University Medical Center Groningen
Groningen
9713
Netherlands
Erasmus University Medical Center
Rotterdam
3075
Netherlands
Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau
Barcelona
Spain
Hospital Universitario 12 de Octubre
Madrid
Spain
King's Health Partners
London
United Kingdom
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
FG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
FG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
FG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
FG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose:
FG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
FG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose:
FG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
FG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
FG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
FG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
FG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
FG0001 subjects
FG0014 subjects
FG0025 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0095 subjects
FG0103 subjects
FG011185 subjects
FG01212 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0001 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0095 subjects
FG0103 subjects
FG011185 subjects
FG01212 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0114 subjects
FG0120 subjects
Death
FG0000 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
progressive disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
BG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
BG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
BG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
BG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
BG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
BG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
BG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
BG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
BG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
BG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
BG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
BG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0014
BG0025
BG0034
BG0043
BG0054
BG0066
BG0076
BG0086
BG0095
BG0103
BG011185
BG01212
BG013244
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052± NAThere is only 1 participant in cohort.0-a. Standard deviation is not applicable
BG00159.3± 21.28
BG00256.4± 17.10
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18 - 65
Title
Measurements
BG0001
BG0013
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Netherlands
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Efficacy Based on CR or CRh Rate
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], molecular CR [CRm], or CRh per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
Posted
Count of Participants
Participants
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Overall Complete Response Rate
Rate of CR + CRh + CRi (CR with incomplete blood cell recovery [CR with incomplete neutrophil {CRn}or platelet recovery {CRp}]) + MLFS (morphologic leukemia-free state)
Posted
Count of Participants
Participants
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose:
Secondary
CR Rate
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], or molecular CR [CRm] per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
Posted
Count of Participants
Participants
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Secondary
CRh Rate
Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.
CRh is defined as: CR with partial hematologic recovery.
Posted
Count of Participants
Participants
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
OG005
Secondary
Overall Response Rate
Proportion of patients achieving a best response of CR, CRh, CRi, MLFS or partial response per Interworking Group AML response criteria.
CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.
CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.
CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.
CRh is defined as: CR with partial hematologic recovery.
Posted
Count of Participants
Participants
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Secondary
HSCT Rate
Rate of successful hematopoietic stem cell transplantation (HSCT) after the start flotetuzumab treatment and before subsequent therapy.
Posted
Count of Participants
Participants
up to 8 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Secondary
Occurrence of Dose Limiting Toxicity
Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is < 33% during the first cycle of MGD006 treatment.
DLT were reported for dose escalation cohorts only (cohort 0-8)
Posted
Count of Participants
Participants
Cycle 1 of a 28 day cycle.
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Secondary
Occurrence of Adverse Events (AEs)
Cycle 1 through end of treatment
Posted
Count of Participants
Participants
up to 9 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Secondary
Occurrence of Serious Adverse Events (SAEs)
Posted
Count of Participants
Participants
up to 9 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Participants With Anti-drug Antibodies
Occurrence of anti-drug antibody
Participants were analyzed for the development of ADA regardless of dose level. Presence or absence of ADA is not related to dose level. The relevant information is the change from one status (positive, negative, or not tested) to a different status.
Posted
Count of Participants
Participants
Study Day 1, then every 28 days through 28-days after the last dose (up to 8 months)
ID
Title
Description
OG000
All Dose Levels
Participants were analyzed for the development of ADA regardless of dose level. Presence or absence of ADA is not related to dose level. The relevant information is the change from one status (positive, negative, or not tested) to a different status.
Units
Counts
Participants
OG000
Secondary
Number of Patients With Infusion Related Reaction (IRR)
Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS
Posted
Count of Participants
Participants
During study drug administration (up to 8 months)
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Number of Patients With Cytokine Release Syndrome (CRS)
Posted
Count of Participants
Participants
up to 9 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Maximum Serum Concentration of Flotetuzumab
Measure the pharmacokinetics (PK) of flotetuzumab
The PK analysis was conducted for patients receiving 10, 30, 100, 300, and 500 ng/kg/day. The study drug was administered as continuous IV dosing. Due to the short half-life, Cmax is not influenced by drug administration schedule. The data for all participants treated at a dose, regardless of schedule, were analyzed together. Specimens were collected and individually analyzed for concentrations only in the 700 ng/kg/day, no PK parameters were derived for this dose group.
Posted
Median
Full Range
pg/mL
Study day 1, then every 28 days and 28 days after the last dose (up to 8 months)
ID
Title
Description
OG000
10 ng/kg/Day
All patients treated at 10 mg/kg/day
OG001
30 ng/kg/Day
All patients treated at 30 mg/kg/day
OG002
100 ng/kg/Day
All patients treated at 100 mg/kg/day
OG003
300 ng/kg/Day
All patients treated at 300 mg/kg/day wither 4 days on/3 days off or by continuous infusion.
Secondary
Post-baseline Transfusion Independence Rate
The number of patients who were transfusion-dependent at baseline and did not receive transfusions during any consecutive 56-day period will be calculated. The number of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.
No data was collected regarding transfusion dependency status at baseline or post-baseline.
Posted
56 days
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Secondary
Number of Patients Alive at 6 Months
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Event-free Survival
Time from the first dose of study drug until date of evidence of primary refractory disease to flotetuzumab, relapse from CR, CRh or CRi, or death from any cause, whichever occurs first.
Posted
Median
95% Confidence Interval
months
Up to 2 years
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Mortality Rate
number of deaths from any cause within 30, 60, 90, or 180 days of first dose of study drug
Posted
Count of Participants
Participants
Throughout the study, up to 3 years.
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Secondary
Number of Patients Alive at 12 Months
Number of patients alive at 1 year from first dose of study drug
Posted
Count of Participants
Participants
1 year
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Secondary
Median Time to Response
Time from first dose of study drug to first CR, CRh, CRi, or MLFS
Posted
Median
95% Confidence Interval
months
up to 14 months
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Secondary
Duration of Response of Patients With CR or CRh
Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.
Analysis is based on the number of participants who had a CR or CRh as reported in Outcome Measure 1
Posted
Mean
Standard Deviation
Months
Up to 2 years
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
Secondary
Overall Survival
Time from first dose to death from any cause
Posted
Median
Standard Deviation
months
Up to 2 years
ID
Title
Description
OG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
OG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
OG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
OG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Secondary
Rate of Hospitalization for Patients in the Expansion Cohort After Initial Discharge
Initial dosing procedures were performed as a hospital inpatient. Incidence rate of hospitalization after discharge from the hospital will be calculated
Posted
Count of Participants
Participants
up to 8 months
ID
Title
Description
OG000
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
Units
Counts
Participants
OG000185
Secondary
Duration of Hospitalization for Patients in the Expansion Cohort
Duration of hospitalization will be characterized after discharge from initial dosing will be characterized
Posted
Count of Participants
Participants
up to 8 months
ID
Title
Description
OG000
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
Units
Counts
Participants
OG000185
Title
Time Frame
Throughout the study, up to 95 months.
Description
AEs are based on physical exam, patient reports, and significant abnormal laboratory values.
AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment.
Only patients who received study treatments were assessed for safety. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.[](streamdown:incomplete-link)
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 0-a
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
0
1
0
1
1
1
EG001
Cohort 0-b
Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
3
4
1
4
4
4
EG002
Cohort 0-c
Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
3
5
0
5
5
5
EG003
Cohort 0-d
Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
4
4
2
4
4
4
EG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
2
3
1
3
3
3
EG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
2
4
2
4
4
4
EG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
6
6
2
6
6
6
EG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose
6
6
1
6
6
6
EG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose
5
6
0
6
6
6
EG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
5
5
3
5
5
5
EG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose
3
3
1
3
3
3
EG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
144
185
100
185
185
185
EG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dos Ruxolitinib: Oral inhibitor of JAK kinase
12
12
6
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected3 at risk
EG0119 affected185 at risk
EG0121 affected12 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastric ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Generalised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Localised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Epstein-Barr virus infection reactivation
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Epstein-Barr viraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Scedosporium infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Wound infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Coronavirus test positive
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Liver function test increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose:
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose:
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose:
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose:
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose:
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:
Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0101
OG01127
OG0124
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0100
OG01113
OG0122
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG00014
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0113
OG0122
OG004
Cohort 1
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose: Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0071
OG0080
OG0092
OG0101
OG01135
OG0124
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose:
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG01110
OG0121
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG0110
OG0120
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0033
OG0041
OG0052
OG0062
OG0071
OG0080
OG0093
OG0101
OG011100
OG0126
244
Title
Denominators
Categories
Title
Measurements
Not tested at baseline, not tested on study
OG000144
Not tested at baseline, all negative on study
OG0004
Not tested at baseline, at least 1 positive on study
OG0000
Negative at baseline, not tested on study
OG00025
Negative at baseline, all negative on study
OG00070
Negative at baseline, at least 1 positive on study
OG0001
Positive at baseline, not tested on study
OG0000
Positive at baseline, all negative on study
OG0000
Positive at baseline, at least 1 positive on study
OG0000
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0043
OG0053
OG0065
OG0076
OG0085
OG0095
OG0102
OG01178
OG0128
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose:
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG011107
OG0124
OG004
500 ng/kg/Day
All patients treated at 500 mg/kg/day wither 4 days on/3 days off or by continuous infusion.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0039
OG004212
Title
Denominators
Categories
Title
Measurements
OG00016.1(5.55 to 25.3)
OG00134.5(21.0 to 55.0)
OG00282.8(68.2 to 180)
OG003177(43.6 to 998)
OG004185(51.8 to 754)
Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0033
OG0040
OG0050
OG0062
OG0072
OG0082
OG0091
OG0101
OG01142
OG0126
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG001NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG002NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG003NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG004NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG005NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG006NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG007NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG008NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG009NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG010NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG011NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG012NA(NA to NA)Not estimable due to an insufficient number of participants with events.
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
Mortality at 0-30 days
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0070
OG0081
OG0091
OG0100
OG01123
OG0122
Mortality at 31-60 days
OG0000
OG0011
OG0020
OG0030
OG004
Mortality at 61-90 days
OG0000
OG0011
OG0021
OG0030
OG004
Mortality at 91- >180 days
OG0001
OG0012
OG0022
OG0034
OG004
unknown
OG0000
OG0010
OG0021
OG0030
OG004
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0044
OG0053
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0072
OG0081
OG0090
OG0101
OG01116
OG0123
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG008
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG00543
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG001NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG002NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG003NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG004NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG005NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG006NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG007NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG008NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG009NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG010NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG011NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG012NA(NA to NA)Not estimable due to an insufficient number of participants with events.
OG005
Cohort 2
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0100
OG01116
OG0124
Title
Denominators
Categories
Title
Measurements
OG0074.0± NAThere was only 1 response in this cohort.
OG0092.3± NAThere was only 1 response in this cohort
OG0111.4± 1.04
OG0121.1± 1.56
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
OG006
Cohort 2a
Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
OG007
Cohort 3
Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose
OG008
Cohort 6
Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose
OG009
Cohort 7
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG010
Cohort 8
Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose
OG011
MTD Expansion
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose
OG012
MTD Expansion With Ruxolitinib
Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase
Units
Counts
Participants
OG0001
OG0014
OG0025
OG0034
OG0043
OG0054
OG0066
OG0076
OG0086
OG0095
OG0103
OG011185
OG01212
Title
Denominators
Categories
Title
Measurements
OG000NA± NANot estimable due to an insufficient number of participants with events.
OG001NA± NANot estimable due to an insufficient number of participants with events.
OG002NA± NANot estimable due to an insufficient number of participants with events.
OG003NA± NANot estimable due to an insufficient number of participants with events.
OG004NA± NANot estimable due to an insufficient number of participants with events.
OG005NA± NANot estimable due to an insufficient number of participants with events.
OG006NA± NANot estimable due to an insufficient number of participants with events.
OG007NA± NANot estimable due to an insufficient number of participants with events.
OG008NA± NANot estimable due to an insufficient number of participants with events.
OG009NA± NANot estimable due to an insufficient number of participants with events.
OG010NA± NANot estimable due to an insufficient number of participants with events.
OG011NA± NANot estimable due to an insufficient number of participants with events.
OG012NA± NANot estimable due to an insufficient number of participants with events.
Title
Denominators
Categories
Title
Measurements
OG000NANot estimable due to an insufficient number of participants with events.
Denominators
Categories
Title
Measurements
OG000NANot estimable due to an insufficient number of participants with events.