To Assess the Safety and Tolerability of INCB000928 in Pa... | NCT04582539 | Trialant
NCT04582539
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Oct 22, 2025Actual
Enrollment
22Actual
Phase
Phase 1Phase 2
Conditions
Myelodysplastic Syndromes
Multiple Myeloma
Anemia
Interventions
INCB000928
Countries
United States
France
Italy
Protocol Section
Identification Module
NCT ID
NCT04582539
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 00928-105
Secondary IDs
ID
Type
Description
Link
2020-002771-35
EudraCT Number
Brief Title
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
Official Title
A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
Acronym
LIMBER
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic Business Decision
Expanded Access Info
No
Start Date
Aug 19, 2021Actual
Primary Completion Date
Aug 15, 2024Actual
Completion Date
Aug 15, 2024Actual
First Submitted Date
Oct 6, 2020
First Submission Date that Met QC Criteria
Oct 6, 2020
First Posted Date
Oct 9, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 15, 2025
Results First Submitted that Met QC Criteria
Oct 7, 2025
Results First Posted Date
Oct 22, 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
Oct 7, 2025
Last Update Posted Date
Oct 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
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
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Detailed Description
Not provided
Conditions Module
Conditions
Myelodysplastic Syndromes
Multiple Myeloma
Anemia
Keywords
Myelodysplastic Syndromes
Multiple Myeloma
Anemia
LIMBER
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
22Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCB000928
Experimental
INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Drug: INCB000928
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB000928
Drug
INCB000928 will be administered once daily.
INCB000928
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
up to 950 days
Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to one of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
up to 950 days
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicities occurring during the first study drug treatment cycle, from C1D1 up to and including Cycle 1 Day 28 (per regimen cycle schedule), except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
up to Day 28
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Anemia Response
Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Agreement to avoid pregnancy or fathering children.
Participants who are transfusion-dependent or present with symptomatic anemia
For MDS participants:
Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
Not requiring cytoreductive therapy other than hydroxyurea.
BM and peripheral blood myeloblast count < 10%.
Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes.
For MM participants:
Histologically confirmed diagnosis of MM.
After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab.
Exclusion Criteria:
Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
Any major surgery within 28 days before the first dose of study drug.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.
History of clinically significant or uncontrolled cardiac disease.
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful.
Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
Diagnosis of chronic liver disease.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ekatarine Asatiani, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Stanford Cancer Center
Palo Alto
California
94304
United States
University of Miami
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 8 study centers in the United States, France, and Italy.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
FG001
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
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
Dec 6, 2023
Aug 14, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Sequential 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
up to Day 28
Recommended Dose for Expansion (RDE)
RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.
up to Day 28
up to Week 24
Duration of Anemia Response
Duration of anemia response was defined as the interval from the first onset of anemia response to the earliest date of loss of anemia response that persisted for at least 4 weeks or death from any cause. Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
up to 920 days
Percentage of Participants With RBC-transfusion Independence (TI)
Participants with RBC-transfusion independence were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
up to Week 24
Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks of Treatment
Participants with RBC-TI were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
up to 920 days
Rate of Red Blood Cell (RBC) Transfusion From Week 12 Through Week 24
The rate of RBC transfusion was defined as the average number of RBC units per participant-month during the treatment period.
from Week 12 through Week 24
The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
Baseline Hgb was measured up to 8 weeks prior to the first dose administration of zilurgisertib. The baseline Hgb was defined as the average of all eligible Hgb assessments. The Hgb assessment(s) within the window from the date received RBC transfusion+1 day to the date received RBC transfusion+14 days that didn't trigger another transfusion were excluded.
up to Week 24
Overall Response Rate (ORR) in MDS Participants
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). For MDS, CR: bone marrow with ≤5% myeloblasts with normal maturation of all cell lines; HgB ≥11 g/dl, neutrophils ≥1.0x10^9/Liter (L), platelets ≥100x10^9/L, and no blasts in the peripheral blood. For MDS, PR: all CR criteria, but bone marrow blasts decreased by ≥50% over pretreatment but still >5%; cellularity and morphology not relevant. For MDS/MPN overlap syndromes, CR: bone marrow with ≤5% myeloblasts; no osteomyelofibrosis or ≤Grade 1 fibrosis; white blood cells ≤10X10^9 cells/L, HgB ≥11 g/dL, platelets ≥100x10^9/L/≤450x10^9/L, neutrophils ≥1.0x10^9/L, no blasts, neutrophil precursors reduced to ≤2%, monocytes ≤1x10^9/L in peripheral blood; complete resolution of medullary disease. For MDS/MPN overlap syndromes, PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50%, but remaining >5% of cellularity.
up to 920 days
Percentage of MDS Participants With an Event of Progression or Death
Participants with MDS/MPN overlap syndromes were excluded from analysis. Data have been reported as the percentage of participants with an event of progression or death rather than median PFS (the interval from the first dose of study drug until the first documented progression or death) because 2 participants had an event of PFS or death. It was pre-specified in the SAP that the number of MDS participants with documented progression or death was to be summarized.
up to 920 days
Percentage of Participants With an Event of Leukemia or Death
Data have been reported as the percentage of participants with an event of leukemia or death rather than LFS (the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause) because 3 participants had an event of leukemia or death. It was pre-specified in the SAP that the number of participants with leukemia transformation or death was to be summarized.
up to 920 days
ORR in Multiple Myeloma (MM) Participants
ORR was defined as the percentage of participants with stringent CR, CR, very good PR, and PR.
up to 920 days
PFS in MM Participants
PFS was defined as the interval from the first dose of study drug until the first documented progression or death.
up to 920 days
Cmax of Zilurgisertib
Cmax was defined as the maximum concentration of zilurgisertib.
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6 hours post-dose
Tmax of Zilurgisertib
tmax was defined as the time to the maximum observed concentration of zilurgisertib.
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
AUClast of Zilurgisertib
AUClast was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Ctrough of Zilurgisertib
Ctrough was defined as the lowest concentration of zilurgisertib.
Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1
Percentage change was calculated as the ([post-baseline value minus the baseline value] / [baseline value]) * 100.
from Cycle 1 Day 15 to Cycle 7 Day 1
Change From Baseline in Ferritin
Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
Change From Baseline in Hemoglobin at the End of Treatment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
up to 950 days
Miami
Florida
33136
United States
Florida Cancer Specialists
Sarasota
Florida
34232
United States
Tulane Comprehensive Cancer Center
New Orleans
Louisiana
70112
United States
Barbara Ann Karmanos Cancer Hospital
Detroit
Michigan
48201
United States
University of Cincinnati
Cincinnati
Ohio
45219
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Md Anderson Cancer Center
Houston
Texas
77030
United States
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes
44093
France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite
69310
France
Institut Gustave Roussy
Villejuif
94800
France
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna
40138
Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence
50134
Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia
27100
Italy
Irccs Istituto Clinico Humanitas
Rozzano
20089
Italy
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
FG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
FG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
FG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
FG0004 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG0043 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG0043 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Participant Started New Therapy; Did Not Return to Clinic
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
BG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
BG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
BG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
BG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0024
BG0035
BG0043
BG00521
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
BG00068.8± 4.50
BG00174.6± 3.78
BG00278.5± 6.19
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Full Analysis Set-MDS: all participants with myelodysplastic syndromes (MDS) or MDS/myeloproliferative neoplasm (MPN) overlap syndromes who received at least 1 dose of zilurgisertib
Posted
Count of Participants
Participants
up to 950 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0024
OG003
Primary
Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to one of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Full Analysis Set-MDS
Posted
Count of Participants
Participants
up to 950 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Primary
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicities occurring during the first study drug treatment cycle, from C1D1 up to and including Cycle 1 Day 28 (per regimen cycle schedule), except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
DLT Evaluable Population: all participants in the FAS Population who met the following criteria: observed for at least the first treatment cycle (i.e., 28 days); received ≥75% of doses of study treatment at the level assigned to that cohort (i.e., 21 days of treatment) or had a DLT during the first study treatment cycle; did not receive any strong or potent CYP3A4/5 inhibitor or inducer during the first study drug treatment cycle (DLT assessment period); was not part of a backfill cohort
Posted
Count of Participants
Participants
up to Day 28
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Primary
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
Full Analysis Set-MDS
Posted
Number
milligrams
up to Day 28
ID
Title
Description
OG000
All Participants
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG000
Primary
Recommended Dose for Expansion (RDE)
RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.
Full Analysis Set-MDS
Posted
Number
milligrams
up to Day 28
ID
Title
Description
OG000
All Participants
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG00021
Secondary
Percentage of Participants With Anemia Response
Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
Full Analysis Set-MDS. Participants must have been on treatment for ≥8 consecutive weeks or discontinued treatment before Week 8. Only participants who were transfusion independent at baseline were analyzed. The 95% confidence interval was calculated using exact binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to Week 24
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Secondary
Duration of Anemia Response
Duration of anemia response was defined as the interval from the first onset of anemia response to the earliest date of loss of anemia response that persisted for at least 4 weeks or death from any cause. Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
Full Analysis Set-MDS. Participants must have been on treatment for ≥8 consecutive weeks and have discontinued treatment before Week 8. Only participants who were transfusion independent at baseline and had a response were analyzed.
Posted
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Secondary
Percentage of Participants With RBC-transfusion Independence (TI)
Participants with RBC-transfusion independence were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
Full Analysis Set-MDS. Only participants who were transfusion dependent at Baseline were analyzed. The 95% confidence interval was calculated using exact binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to Week 24
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Secondary
Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks of Treatment
Participants with RBC-TI were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
Full Analysis Set-MDS. Only participants who were transfusion dependent at Baseline and achieved transfusion independence were analyzed.
Posted
Median
Standard Error
days
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Secondary
Rate of Red Blood Cell (RBC) Transfusion From Week 12 Through Week 24
The rate of RBC transfusion was defined as the average number of RBC units per participant-month during the treatment period.
Full Analysis Set-MDS. Only participants who were on treatment for at least 78 days were included in the analysis.
Posted
Mean
Standard Deviation
RBC units per participant-month
from Week 12 through Week 24
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Secondary
The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
Baseline Hgb was measured up to 8 weeks prior to the first dose administration of zilurgisertib. The baseline Hgb was defined as the average of all eligible Hgb assessments. The Hgb assessment(s) within the window from the date received RBC transfusion+1 day to the date received RBC transfusion+14 days that didn't trigger another transfusion were excluded.
Full Analysis Set-MDS. Participants were included in the mean change from baseline in hemoglobin value analysis if the participant was in the FAS and met both of the following criteria: a. was on treatment for more than 8 weeks; b. had ≥1 valid post-baseline Hgb assessment(s).
Posted
Mean
Standard Deviation
grams per liter
up to Week 24
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Secondary
Overall Response Rate (ORR) in MDS Participants
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). For MDS, CR: bone marrow with ≤5% myeloblasts with normal maturation of all cell lines; HgB ≥11 g/dl, neutrophils ≥1.0x10^9/Liter (L), platelets ≥100x10^9/L, and no blasts in the peripheral blood. For MDS, PR: all CR criteria, but bone marrow blasts decreased by ≥50% over pretreatment but still >5%; cellularity and morphology not relevant. For MDS/MPN overlap syndromes, CR: bone marrow with ≤5% myeloblasts; no osteomyelofibrosis or ≤Grade 1 fibrosis; white blood cells ≤10X10^9 cells/L, HgB ≥11 g/dL, platelets ≥100x10^9/L/≤450x10^9/L, neutrophils ≥1.0x10^9/L, no blasts, neutrophil precursors reduced to ≤2%, monocytes ≤1x10^9/L in peripheral blood; complete resolution of medullary disease. For MDS/MPN overlap syndromes, PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50%, but remaining >5% of cellularity.
Full Analysis Set-MDS only. Participants with MDS/MPN overlap syndromes were excluded from analysis. The 95% confidence interval was calculated using exact binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Secondary
Percentage of MDS Participants With an Event of Progression or Death
Participants with MDS/MPN overlap syndromes were excluded from analysis. Data have been reported as the percentage of participants with an event of progression or death rather than median PFS (the interval from the first dose of study drug until the first documented progression or death) because 2 participants had an event of PFS or death. It was pre-specified in the SAP that the number of MDS participants with documented progression or death was to be summarized.
Full Analysis Set-MDS only. Participants with MDS/MPN overlap syndromes were excluded from analysis.
Posted
Number
percentage of participants
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Secondary
Percentage of Participants With an Event of Leukemia or Death
Data have been reported as the percentage of participants with an event of leukemia or death rather than LFS (the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause) because 3 participants had an event of leukemia or death. It was pre-specified in the SAP that the number of participants with leukemia transformation or death was to be summarized.
Full Analysis Set-MDS
Posted
Number
percentage of participants
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Secondary
ORR in Multiple Myeloma (MM) Participants
ORR was defined as the percentage of participants with stringent CR, CR, very good PR, and PR.
Full Analysis Set. No participants with MM were enrolled.
Posted
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Secondary
PFS in MM Participants
PFS was defined as the interval from the first dose of study drug until the first documented progression or death.
Full Analysis Set. No participants with MM were enrolled.
Posted
up to 920 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Secondary
Cmax of Zilurgisertib
Cmax was defined as the maximum concentration of zilurgisertib.
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 postdose plasma sample (1 PK measurement). Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
Posted
Mean
Standard Deviation
nanomolar
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6 hours post-dose
ID
Title
Description
OG000
Zilurgisertib 25 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
OG001
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Secondary
Tmax of Zilurgisertib
tmax was defined as the time to the maximum observed concentration of zilurgisertib.
PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
Posted
Median
Full Range
hours
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib 25 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
OG001
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Secondary
AUClast of Zilurgisertib
AUClast was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
Posted
Mean
Standard Deviation
nanomolar x hour
Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib 25 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
OG001
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Secondary
Ctrough of Zilurgisertib
Ctrough was defined as the lowest concentration of zilurgisertib.
PK Evaluable Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nanomolar
Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Secondary
Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1
Percentage change was calculated as the ([post-baseline value minus the baseline value] / [baseline value]) * 100.
Pharmacodynamic (PD) Evaluable Population: all participants who received at least 1 dose of zilurgisertib and provided at least 1 plasma/serum sample (1 PD measurement)
Posted
Mean
Standard Deviation
percent change
from Cycle 1 Day 15 to Cycle 7 Day 1
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Secondary
Change From Baseline in Ferritin
Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
Full Analysis Set-MDS. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nanograms per milliliter
Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Secondary
Change From Baseline in Hemoglobin at the End of Treatment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Full Analysis Set-MDS. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
grams per liter
up to 950 days
ID
Title
Description
OG000
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
OG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Time Frame
up to 950 days
Description
Analysis was conducted in the Full Analysis Set-MDS, comprised of all participants with myelodysplastic syndromes (MDS) or MDS/myeloproliferative neoplasm (MPN) overlap syndromes who received at least 1 dose of zilurgisertib.
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
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
1
4
2
4
4
4
EG001
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
1
5
1
5
5
5
EG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
0
4
2
4
4
4
EG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
1
5
2
5
5
5
EG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
0
3
0
3
2
3
EG005
Total
Total
3
21
7
21
20
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0053 events2 affected21 at risk
COVID-19
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0053 events3 affected21 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events2 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bankart lesion
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0003 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cyst
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0024 events2 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Hyperthermia
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypofibrinogenaemia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA 27
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Malaise
General disorders
MedDRA 27
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Mastitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 27
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Serum ferritin increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0024 events2 affected4 at risk
EG003
Vascular neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Weight increased
Investigations
MedDRA 27
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
The sponsor terminated study enrollment as a strategic decision. Due to early study termination, no participants were enrolled in the expansion stage of the study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0022
OG0032
OG0042
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
21
Title
Denominators
Categories
Title
Measurements
OG000NAThe maximum sample size for each dose level was 9. Given that there were 2 DLT-evaluable participants at the 600 mg QD dose level and 1 DLT was observed, the dose should have been de-escalated. As a result, the dose escalation was incomplete at the time of study termination, and the MTD could not be determined since the stopping rule had not been met.
Title
Denominators
Categories
Title
Measurements
OG000NAThe RDE was not established because, at the time of early study termination, dose escalation was ongoing and the dose that had evidence of the best pharmacologic activity while being below the MTD had not yet been identified.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0002
OG0014
OG0022
OG0034
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 84.2)
OG0010.0(0.0 to 60.2)
OG0020.0(0.0 to 84.2)
OG0030.0(0.0 to 60.2)
OG0040.0(0.0 to 84.2)
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG0031
OG0041
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 84.2)
OG001100.0(2.5 to 100.0)
OG0020.0(0.0 to 84.2)
OG0030.0(0.0 to 97.5)
OG0040.0(0.0 to 97.5)
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG00160± NAStandard error cannot be calculated for a single participant.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG0002.53± 1.955
OG0011.34± 0.948
OG0023.01± 2.955
OG0032.71± 2.232
OG0041.19± 2.067
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG0002.19± 2.782
OG0019.73± 2.842
OG0022.51± 3.681
OG0034.92± 10.240
OG0046.59± 4.229
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
OG002
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 60.2)
OG0020.0(0.0 to 70.8)
OG0030.0(0.0 to 52.2)
OG0040.0(0.0 to 70.8)
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG0010.0
OG0020.0
OG00320.0
OG0040.0
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00120.0
OG0020.0
OG00320.0
OG0040.0
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG005
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0001
OG0014
OG0024
OG0034
OG0044
OG0052
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0052
Title
Measurements
OG00079.9± NAStandard deviation was not calculated for a single participant.
OG001181± 80.4
OG002249± 100
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
OG003
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG005
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0001
OG0014
OG0024
OG0034
OG0044
OG0052
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0052
Title
Measurements
OG0002.0(NA to NA)Min, max are not reported for a single participant.
OG0012.0(2.0 to 4.0)
OG0022.0(2.0 to 2.0)
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
OG003
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG005
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0001
OG0014
OG0024
OG0034
OG0044
OG0052
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0052
Title
Measurements
OG000343± NAStandard deviation was not calculated for a single participant.
OG001749± 312
OG0021070± 471
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0034
OG0042
Title
Denominators
Categories
Title
Measurements
OG000214± 91.8
OG001304± 175
OG002619± 241
OG003981± 3130
OG004NA± NATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
OG003
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG0043
Title
Denominators
Categories
Title
Measurements
OG000-24.53± 41.69
OG001-16.25± 47.06
OG002-11.25± 39.97
OG003-59.02± 32.35
OG004-63.79± 44.23
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0035
OG0043
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0035
ParticipantsOG0043
Title
Measurements
OG0001022.35± 634.096
OG001930.18± 697.078
OG0022092.25± 1220.166
OG003
CFB at Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0033
CFB at Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
CFB at Cycle 2 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
CFB at Cycle 3 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
CFB at Cycle 4 Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0035
CFB at Cycle 5 Day 1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
CFB at Cycle 6 Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
CFB at Cycle 7 Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0032
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
OG004
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0035
OG0043
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0035
ParticipantsOG0043
Title
Measurements
OG00077.7750± 5.83688
OG00175.7200± 4.00899
OG00274.9354± 5.98330
OG003
Change from Baseline at end of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0055 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0055 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0055 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected21 at risk
2 events
2 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0042 events1 affected3 at risk
EG0056 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
5 at risk
EG0040 events0 affected3 at risk
EG0054 events4 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0041 events1 affected3 at risk
EG0055 events4 affected21 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0042 events1 affected3 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
5 at risk
EG0041 events1 affected3 at risk
EG0056 events6 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected3 at risk
EG0056 events4 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected21 at risk
569
± 291
OG0041950± 652
OG005NA± NATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG001350± 131
OG002636± 330
OG0031360± 613
OG0042620± 4620
OG005NA± NATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
3.0
(2.0 to 4.0)
OG0042.0(2.0 to 2.0)
OG005NA(NA to NA)Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0012.0(2.0 to 6.0)
OG0022.0(2.0 to 2.0)
OG0033.0(2.0 to 6.0)
OG0042.0(2.0 to 4.0)
OG005NA(NA to NA)Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
2540
± 1150
OG0048050± 2680
OG005NA± NATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0011890± 749
OG0023090± 1620
OG0036850± 3050
OG00412300± 26100
OG005NA± NATwo participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
2034.42
± 1329.794
OG0041469.00± 1191.873
ParticipantsOG0042
Title
Measurements
OG00047.67± 43.501
OG001-65.24± 57.388
OG002203.25± 523.789
OG003-98.83± 567.584
OG004-110.00± 24.042
ParticipantsOG0042
Title
Measurements
OG000292.00± 161.220
OG00117.30± 31.109
OG00267.50± 140.950
OG003-109.77± 98.223
OG004-96.00± 56.569
ParticipantsOG0042
Title
Measurements
OG000101.65± 245.814
OG00170.03± 76.619
OG002154.50± 453.658
OG003-92.87± 364.312
OG004135.00± 200.818
ParticipantsOG0043
Title
Measurements
OG000307.58± 709.602
OG001-6.70± 46.054
OG002532.00± 833.804
OG003353.77± 314.682
OG004-383.00± 536.324
ParticipantsOG0042
Title
Measurements
OG000409.83± 689.052
OG001-21.15± 48.295
OG002875.00± 649.850
OG003619.00± 275.281
OG004-153.50± 82.731
ParticipantsOG0042
Title
Measurements
OG000349.00± 680.559
OG001172.00± NAStandard deviation was not calculated for a single participant.
OG002574.00± 394.335
OG003516.10± 502.323
OG004-106.50± 211.425
ParticipantsOG0040
Title
Measurements
OG000297.67± 614.180
OG001488.50± 152.028
OG002347.33± 362.417
OG003442.15± 264.246
ParticipantsOG0040
Title
Measurements
OG000365.50± 658.316
OG001971.00± NAStandard deviation was not calculated for a single participant.