INCB000928 Administered as a Monotherapy or in Combinatio... | NCT04455841 | Trialant
NCT04455841
Sponsor
Incyte Corporation
Status
Active, not recruiting
Last Update Posted
May 14, 2026Actual
Enrollment
84Actual
Phase
Phase 1Phase 2
Conditions
Anemia
Post-essential Thrombocythemia Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Interventions
INCB000928
ruxolitinib
Countries
United States
Canada
France
Italy
Japan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04455841
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 00928-104
Secondary IDs
ID
Type
Description
Link
2023-503625-19-00
Registry Identifier
EU CT Number
2020-004029-21
EudraCT Number
Brief Title
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Official Title
A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 19, 2021Actual
Primary Completion Date
Apr 1, 2025Actual
Completion Date
Nov 26, 2027Estimated
First Submitted Date
Jun 19, 2020
First Submission Date that Met QC Criteria
Jun 29, 2020
First Posted Date
Jul 2, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 19, 2026
Results First Submitted that Met QC Criteria
Apr 20, 2026
Results First Posted Date
May 12, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 12, 2026
Last Update Posted Date
May 14, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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 or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Detailed Description
Not provided
Conditions Module
Conditions
Anemia
Post-essential Thrombocythemia Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Keywords
anemia
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
84Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment Group A (TGA)
Experimental
INCB000928 will be administered once daily (QD).
Drug: INCB000928
Treatment Group B (TGB)
Experimental
INCB000928 will be administered in combination with ruxolitinib.
Drug: INCB000928
Drug: ruxolitinib
Treatment Group C (TGC)
Experimental
INCB000928 will be administered in combination with ruxolitinib.
Drug: INCB000928
Drug: ruxolitinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB000928
Drug
INCB000928 will be administered at protocol defined dose.
Treatment Group A (TGA)
Treatment Group B (TGB)
Treatment Group C (TGC)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug/treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug.
up to approximately 4 years
Number of Participants With Any ≥Grade 3 TEAE and Any Treatment-emergent SAE
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. 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 approximately 4 years
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicity occurring during the first treatment cycle, from Cycle 1 Day 1 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. The DLT-Evaluable Population included all non-backfill participants eligible for dose escalation who met the criteria outlined in the Analysis Population field.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Anemia Response
Anemia response was defined as (a) a hemoglobin (Hgb) increase of 1.5 grams per deciliter (g/dL) relative to baseline for any "rolling" 12-week period (84 days with each assessment that met this requirement) during the first 24 weeks of treatment if transfusion independent (TI) at baseline; or (b) transfusion independence for any "rolling" 12-week period (absence of any red blood cell [RBC] transfusion over any 84-day period) during the first 24 weeks of treatment if transfusion dependent (TD) at baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).
Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 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. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
ECOG performance status score of the following:
0 or 1 for the dose-escalation stages.
0, 1, or 2 for the dose-expansion stage.
Life expectancy is greater than 6 months
Agreement to avoid pregnancy or fathering children.
Ineligible to receive or have not responded to available therapies for anemia such as ESAs.
For TGA:
Participants previously treated with JAK inhibitors for at least 12 weeks.
Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
For TGB:
Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.
For TGC:
Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib treatment.
Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.
Exclusion Criteria:
Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Laboratory Values outside of protocol defined range at screening.
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.
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 in 25 study centers in Canada, France, Italy, Japan, the United Kingdom, and the United States. Data collected through a cut off date of 12 June 2025 have been reported.
Recruitment Details
Following a strategic decision (not based on safety concerns) to close study enrollment, the dose-expansion phase (Phase 2) was not conducted.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
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
Feb 20, 2025
Mar 19, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
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
ruxolitinib
Drug
Ruxolitinib will be administered at protocol defined dose.
Treatment Group B (TGB)
Treatment Group C (TGC)
from Cycle 1 Day 1 to Cycle 1 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. 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.
from Cycle 1 Day 1 to Cycle 1 Day 28
Recommended Dose for Expansion (RDE)
The RDE was defined as a pharmacodynamically active dose. The RDE was determined in an independent fashion by evaluation of all available data (i.e., safety, pharmacokinetic, and pharmacodynamic data) from the respective dose-escalation stage of the study for further investigation in the expansion cohort, including safety (e.g., low-grade but chronic toxicities, dose reduction, dose interruption, or missed doses of zilurgisertib and/or ruxolitinib). The RDE(s) could not exceed the MTD in each treatment group
from Cycle 1 Day 1 to Cycle 1 Day 28
up to Week 24
Duration of Anemia Response
Duration of anemia response was defined as (a) 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 (for TI participants at baseline); or (b) the duration of the RBC-TI period for participants who achieved RBC-TI for at least 12 consecutive weeks during the first 24 weeks of treatment (for TD participants at baseline).
up to 1530 days
Mean Change From Baseline in the Hgb Value Over 12-week Treatment Periods
Mean change from baseline was assessed as the largest increase from baseline in the mean Hgb values over any rolling 12-week treatment period during the first 24 weeks of treatment. Change from baseline was calculated as the post-baseline value minus the baseline value.
Baseline; up to 24 weeks
Rate of Red Blood Cell (RBC) Transfusion From Week 24 Through Week 48
The rate of RBC transfusion was defined as the average number of RBC units per participant-month during the treatment period.
from Week 24 through Week 48
Splenic Volume Response Rate at Week 24
Splenic volume response rate was defined as the percentage of participants achieving a ≥35% reduction in spleen volume at Week 24 relative to baseline as measured by magnetic resonance imaging or computed tomography scan.
Week 24
Spleen Length Response
Spleen length response was defined as the percentage of participants achieving a ≥50% reduction in spleen length at any visit relative to baseline as measured by palpation.
Week 24
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) (including the morphologic effects of the combination of zilurgisertib with ruxolitinib on bone marrow) according to Tefferi et al (2013) definitions.
Week 24
Progression-free Survival (PFS)
PFS was defined as the interval from the first dose of study treatment until the first documented progression or death according to Tefferi et al (2013) definitions.
Week 24
Leukemia-free Survival (LFS)
LFS was defined as the interval from the first dose of study treatment until the first documented leukemia transformation or death from any cause.
Week 24
Cmax of Zilurgisertib Alone
Cmax was defined as the maximum concentration of zilurgisertib.
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, and 6-8 hours post-dose
Tmax of Zilurgisertib
tmax was defined as the time to the maximum concentration of zilurgisertib.
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, and 6-8 hours post-dose
AUC0-t of Zilurgisertib
AUC0-t was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, 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; Cycle 1 Day 22; Cycles 2, 3, 4, 5, 6, and 7 Day 1; Cycle 2 Day 15
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 1530 days
Irvine
California
92618
United States
Usc Norris Comprehensive Cancer Center
Los Angeles
California
90089
United States
Stanford Cancer Center
Palo Alto
California
94304
United States
Prebys Cancer Center
San Diego
California
92103
United States
Emory University - Winship Cancer Institute
Atlanta
Georgia
30322
United States
Emory University-Winship Cancer Institute
Atlanta
Georgia
30322
United States
Start Midwest
Grand Rapids
Michigan
49546
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Weill Cornell Medical Centers
New York
New York
10065
United States
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
Durham
North Carolina
27705
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Md Anderson Cancer Center
Houston
Texas
77030
United States
Princess Margaret Cancer Center
Toronto
Ontario
M5G 2M9
Canada
McGill University Jewish General Hospital
Montreal
Quebec
H3T1E2
Canada
Centre Hospitalier D'Angers
Angers
49033
France
Institut Paoli Calmettes
Marseille
13273
France
Hospital Saint Louis
Paris
75010
France
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo
24127
Italy
S Orsolas University Hospital Seragnoli Institute of Hematology
Bologna
40138
Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence
50134
Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
Orbassano
10043
Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia
27100
Italy
Ospedale Santa Maria Della Misericordia Perugia
Perugia
06124
Italy
Tokyo Medical and Dental University Hospital
Bunkyō City
113-8519
Japan
Chiba Cancer Center
Chiba
260-8717
Japan
Gifu Municipal Hospital
Gifu
500-8513
Japan
Kansai Medical University Hospital
Hirakata
573-1191
Japan
Kumamoto Shinto General Hospital
Kumamoto
862-8655
Japan
Osaka International Cancer Institute
Osaka
541-8567
Japan
University Hospital of Wales
Cardiff
WLS
CF14 4XW
United Kingdom
United Lincolnshire Hospitals
Boston
PE21 9QS
United Kingdom
Lincoln County Hospital
Lincoln
LN2 5QY
United Kingdom
Royal Cornwall Hospital Truro Sunrise Centre
Truro
TR1 3LJ
United Kingdom
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
FG0004 subjects
FG0014 subjects
FG0026 subjects
FG00311 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG0078 subjects
FG00812 subjects
FG0097 subjects
FG0106 subjects
FG0117 subjects
FG0128 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG0043 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0083 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
FG0026 subjects
FG0037 subjects
FG0041 subjects
FG0052 subjects
FG0063 subjects
FG0077 subjects
FG0089 subjects
FG0097 subjects
FG0106 subjects
FG0116 subjects
FG0128 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0084 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Bone Marrow Transplant
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol-specified Withdrawal Criterion Met
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Followed by Another Department
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG0026
BG00311
BG0044
BG0053
BG0064
BG0078
BG00812
BG0097
BG0106
BG0117
BG0128
BG01384
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
BG00071.0± 12.99
BG00164.5± 5.26
BG00270.0± 4.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White/Caucasian
BG0004
BG0012
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) and Any Treatment-emergent Serious Adverse Event (SAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug/treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug.
Safety Population: all participants who received ≥1 dose of zilurgisertib or ruxolitinib, as applicable. Treatment groups for this population were determined according to the actual treatment the participant received.
Posted
Count of Participants
Participants
up to approximately 4 years
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0014
OG0026
OG003
Primary
Number of Participants With Any ≥Grade 3 TEAE and Any Treatment-emergent SAE
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. 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.
Safety Population
Posted
Count of Participants
Participants
up to approximately 4 years
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Primary
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicity occurring during the first treatment cycle, from Cycle 1 Day 1 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. The DLT-Evaluable Population included all non-backfill participants eligible for dose escalation who met the criteria outlined in the Analysis Population field.
DLT-Evaluable Population: all participants who were observed for at least the first treatment cycle (Day 1 to Day 28), who received ≥75% of doses of study treatment at the level assigned to that cohort (i.e., 21 days of treatment) or who had a DLT during the first study treatment cycle, and who did not receive any strong or potent cytochrome P450 3A4/5 inhibitor/inducer and who did not have a ruxolitinib dose reduction during the first study treatment cycle (DLT assessment period)
Posted
Count of Participants
Participants
from Cycle 1 Day 1 to Cycle 1 Day 28
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
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. 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.
DLT-Evaluable Population
Posted
Number
milligrams
from Cycle 1 Day 1 to Cycle 1 Day 28
ID
Title
Description
OG000
Zilurgisertib Monotherapy QD/BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50, 100, 200, 400, or 600 mg QD or 300 mg BID administered as monotherapy. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib + Ruxolitinib, Add on to Ruxolitinib
Primary
Recommended Dose for Expansion (RDE)
The RDE was defined as a pharmacodynamically active dose. The RDE was determined in an independent fashion by evaluation of all available data (i.e., safety, pharmacokinetic, and pharmacodynamic data) from the respective dose-escalation stage of the study for further investigation in the expansion cohort, including safety (e.g., low-grade but chronic toxicities, dose reduction, dose interruption, or missed doses of zilurgisertib and/or ruxolitinib). The RDE(s) could not exceed the MTD in each treatment group
Safety Population
Posted
Number
milligrams
from Cycle 1 Day 1 to Cycle 1 Day 28
ID
Title
Description
OG000
Zilurgisertib Monotherapy QD/BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50, 100, 200, 400, or 600 mg QD or 300 mg BID administered as monotherapy. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100, 200, 400, or 600 mg QD or 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Percentage of Participants With Anemia Response
Anemia response was defined as (a) a hemoglobin (Hgb) increase of 1.5 grams per deciliter (g/dL) relative to baseline for any "rolling" 12-week period (84 days with each assessment that met this requirement) during the first 24 weeks of treatment if transfusion independent (TI) at baseline; or (b) transfusion independence for any "rolling" 12-week period (absence of any red blood cell [RBC] transfusion over any 84-day period) during the first 24 weeks of treatment if transfusion dependent (TD) at baseline.
Full Analysis Set: participants who received ≥1 dose of zilurgisertib or ruxolitinib, as applicable. Participants must have received treatment with zilurgisertib for ≥24 weeks or discontinued from treatment before 24 weeks due to a study-drug related AE, progressive disease, death, being lost follow-up, or due to lack off efficacy to be included in the analysis. 95% confidence intervals were calculated using exact binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Duration of Anemia Response
Duration of anemia response was defined as (a) 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 (for TI participants at baseline); or (b) the duration of the RBC-TI period for participants who achieved RBC-TI for at least 12 consecutive weeks during the first 24 weeks of treatment (for TD participants at baseline).
Full Analysis Set. Participants must have received treatment with zilurgisertib for ≥24 weeks or must have discontinued from treatment before 24 weeks due to a study-drug related AE, progressive disease, death, being lost follow-up, or due to lack off efficacy to be included in the analysis. Only those participants with an anemia response in the first 24 weeks were analyzed.
Posted
Median
Standard Error
days
up to 1530 days
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Secondary
Mean Change From Baseline in the Hgb Value Over 12-week Treatment Periods
Mean change from baseline was assessed as the largest increase from baseline in the mean Hgb values over any rolling 12-week treatment period during the first 24 weeks of treatment. Change from baseline was calculated as the post-baseline value minus the baseline value.
Full Analysis Set. Participants were analyzed according to the treatment to which they were initially assigned. Only participants with available data (those remaining on study for more than 12 weeks during the first 24 weeks of treatment and who had at least 1 valid Hgb assessment) were analyzed.
Posted
Mean
Standard Deviation
grams per liter
Baseline; up to 24 weeks
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Rate of Red Blood Cell (RBC) Transfusion From Week 24 Through Week 48
The rate of RBC transfusion was defined as the average number of RBC units per participant-month during the treatment period.
Full Analysis Set. Only participants who were on treatment for at least 162 days were included in the analysis.
Posted
Mean
Standard Deviation
RBC units per participant-month
from Week 24 through Week 48
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Splenic Volume Response Rate at Week 24
Splenic volume response rate was defined as the percentage of participants achieving a ≥35% reduction in spleen volume at Week 24 relative to baseline as measured by magnetic resonance imaging or computed tomography scan.
This endpoint was intended to be analyzed in Part 2, which did not enroll participants.
Posted
Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Spleen Length Response
Spleen length response was defined as the percentage of participants achieving a ≥50% reduction in spleen length at any visit relative to baseline as measured by palpation.
This endpoint was intended to be analyzed in Part 2, which did not enroll participants.
Posted
Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) (including the morphologic effects of the combination of zilurgisertib with ruxolitinib on bone marrow) according to Tefferi et al (2013) definitions.
This endpoint was intended to be analyzed in Part 2, which did not enroll participants.
Posted
Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Progression-free Survival (PFS)
PFS was defined as the interval from the first dose of study treatment until the first documented progression or death according to Tefferi et al (2013) definitions.
This endpoint was intended to be analyzed in Part 2, which did not enroll participants.
Posted
Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Leukemia-free Survival (LFS)
LFS was defined as the interval from the first dose of study treatment until the first documented leukemia transformation or death from any cause.
This endpoint was intended to be analyzed in Part 2, which did not enroll participants.
Posted
Week 24
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Cmax of Zilurgisertib Alone
Cmax was defined as the maximum concentration of zilurgisertib.
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of zilurgisertib or ruxolitinib and provided at least 1 post-dose plasma sample (1 PK measurement). Only participants with available data were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomoles per liter (nmol/L)
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Tmax of Zilurgisertib
tmax was defined as the time to the maximum concentration of zilurgisertib.
PK Evaluable Population. Only participants with available data were analyzed.
Posted
Median
Full Range
hours
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
AUC0-t of Zilurgisertib
AUC0-t 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.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x nmol/L
Cycle 1 Day 1 (first dose) and Cycle 1 Day 15 (steady state): pre-dose and 2 hours, 4 hours, and 6-8 hours post-dose
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
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 or ruxolitinib and provided at least 1 postdose plasma/serum sample (1 pharmacodynamic measurement)
Posted
Mean
Standard Deviation
percent change
from Cycle 1 Day 15 to Cycle 7 Day 1
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Secondary
Change From Baseline in Ferritin
Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
Safety Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycle 1 Day 22; Cycles 2, 3, 4, 5, 6, and 7 Day 1; Cycle 2 Day 15
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
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.
Safety Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
grams per liter (g/L)
up to 1530 days
ID
Title
Description
OG000
Zilurgisertib Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Time Frame
From Informed Consent Form signature to ≥30 days after the last study treatment or start of a new anticancer treatment (up to 1560 days)
Description
Adverse events have been reported for the Safety Population, comprised of all participants who received ≥1 dose of zilurgisertib or ruxolitinib, as applicable.
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 Monotherapy 50 mg QD
Participants who were previously treated with Janus-associated kinase (JAK) inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 50 mg administered as monotherapy once daily (QD). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
2
4
1
4
4
4
EG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
0
4
0
4
4
4
EG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
2
6
4
6
6
6
EG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
2
11
3
11
11
11
EG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
0
4
1
4
4
4
EG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
1
3
2
3
3
3
EG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
2
4
3
4
4
4
EG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
1
8
3
8
8
8
EG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
4
12
6
12
12
12
EG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
1
7
4
7
7
7
EG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
1
6
1
6
6
6
EG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
0
7
3
7
7
7
EG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
0
8
2
8
8
8
EG013
Total
Total
16
84
33
84
84
84
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Beta haemolytic streptococcal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Death
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Delirium febrile
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lymph node abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Right ventricular dysfunction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transformation to acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected11 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected8 at risk
EG0134 events4 affected84 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood folate decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Coating in mouth
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected6 at risk
EG003
Electrocardiogram PR prolongation
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0013 events3 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Myelofibrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oedema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Otitis media
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paralysis
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Swelling face
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Temperature intolerance
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transformation to acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anterograde amnesia
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blepharitis
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blood urea increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Brain fog
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac murmur
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dermatochalasis
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Dislocation of vertebra
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Electrocardiogram ST segment elevation
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye oedema
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Furuncle
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Glaucoma
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperferritinaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Injection site dermatitis
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Iron overload
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Joint noise
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Serum ferritin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transient acantholytic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin B1 decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Enrollment in this study was closed following a strategic decision, not based on safety concerns, to discontinue the development of zilurgisertib for the treatment of anemia in myeloproliferative disorders.
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 who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0025
OG0033
OG0042
OG0052
OG0063
OG0075
OG0086
OG0096
OG0103
OG0116
OG0126
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0052
OG0064
OG0074
OG0083
OG0097
OG0104
OG0117
OG0123
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100, 200, 400, or 600 mg QD or 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD or 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG00019
OG00122
OG00210
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be declared based on DLTs. Per protocol, MTD was determined separately for each group. Prior to enrollment stop, 0 DLTs were observed in the monotherapy or the zilurgisertib+ruxolitinib in JAK-naive groups. In the zilurgisertib as add-on group, 1 DLT was observed at the 300 BID dose, which falls within the decision boundaries that require additional dose-level enrollment. Additional enrollment was not completed, so dose escalation was not completed/MTD was not reached.
OG001NAMTD could not be declared based on DLTs. Per protocol, MTD was determined separately for each group. Prior to enrollment stop, 0 DLTs were observed in the monotherapy or the zilurgisertib+ruxolitinib in JAK-naive groups. In the zilurgisertib as add-on group, 1 DLT was observed at the 300 BID dose, which falls within the decision boundaries that require additional dose-level enrollment. Additional enrollment was not completed, so dose escalation was not completed/MTD was not reached.
OG002NAMTD could not be declared based on DLTs. Per protocol, MTD was determined separately for each group. Prior to enrollment stop, 0 DLTs were observed in the monotherapy or the zilurgisertib+ruxolitinib in JAK-naive groups. In the zilurgisertib as add-on group, 1 DLT was observed at the 300 BID dose, which falls within the decision boundaries that require additional dose-level enrollment. Additional enrollment was not completed, so dose escalation was not completed/MTD was not reached.
OG002
Zilurgisertib + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD or 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG00032
OG00137
OG00215
Title
Denominators
Categories
Title
Measurements
OG000NAThe RDE was not established because, at the time of enrollment stop, 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.
OG001NAThe RDE was not established because, at the time of enrollment stop, 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.
OG002NAThe RDE was not established because, at the time of enrollment stop, 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.
OG001
Zilurgisertib Monotherapy 100 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0003
OG0014
OG0025
OG0038
OG0043
OG0052
OG0063
OG0077
OG0087
OG0096
OG0103
OG0115
OG0124
Title
Denominators
Categories
Non-transfusion dependent at baseline
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0087
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0114
ParticipantsOG0121
Title
Measurements
OG0000.0(0.0 to 84.2)
OG0010.0(0.0 to 84.2)
OG00233.3(0.8 to 90.6)
OG003
Transfusion dependent at baseline
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 100 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Title
Denominators
Categories
Non-transfusion dependent at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG002429± NAA standard error cannot be calculated for a single participant.
OG003182± NAA standard error cannot be calculated for a single participant.
OG006691± NAA standard error cannot be calculated for a single participant.
Transfusion dependent at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00311
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0128
Title
Measurements
OG00080.54± 7.447
OG00173.88± 7.973
OG00275.84± 8.801
OG003
Largest increase from baseline
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0036
OG0041
OG0051
OG0063
OG0077
OG0085
OG0096
OG0104
OG0113
OG0123
Title
Denominators
Categories
Title
Measurements
OG0002.32± 3.292
OG0012.16± 0.931
OG0020.06± 0.100
OG0039.46± 17.862
OG0042.69± NAStandard deviation was not calculated for a single participant.
OG0050.00± NAStandard deviation was not calculated for a single participant.
OG0060.06± 0.100
OG0070.90± 2.217
OG0080.07± 0.095
OG0091.75± 3.463
OG0105.01± 6.610
OG0113.08± 2.667
OG01215.85± 25.828
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Cycle 1 Day 1 (first dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG00310
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0127
Title
Measurements
OG000123± 42
OG001333± 43
OG0021056± 46.1
OG003
Cycle 1 Day 15 (steady state)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Cycle 1 Day 1 (first dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG00310
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0127
Title
Measurements
OG0004.0(2.4 to 5.9)
OG0013.0(1.9 to 4.0)
OG0023.99(2.00 to 5.98)
OG003
Cycle 1 Day 15 (steady state)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Cycle 1 Day 1 (first dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG00310
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0127
Title
Measurements
OG000524± 30
OG0011430± 37
OG0024232± 52.3
OG003
Cycle 1 Day 15 (steady state)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0038
OG0044
OG0053
OG0064
OG0078
OG00811
OG0097
OG0105
OG0117
OG0127
Title
Denominators
Categories
Title
Measurements
OG000-38.50± 32.98
OG001-30.46± 28.81
OG002-10.13± 62.13
OG003-30.57± 50.8
OG004-39.36± 34.4
OG005-54.89± 40.6
OG0066.08± 69.09
OG007-44.31± 33.37
OG008-42.44± 48.87
OG009-54.71± 35.36
OG010-45.43± 54.41
OG01156.26± 116.2
OG012-58.00± 39.01
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00311
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0128
Title
Measurements
OG0002715.00± 2657.361
OG0011624.00± 1427.915
OG0021504.15± 1524.183
OG003
Change from baseline at Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0039
Change from baseline at Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
Change from baseline at Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0039
Change from baseline at Cycle 2 Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0039
Change from baseline at Cycle 2 Day 15
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0038
Change from baseline at Cycle 3 Day 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
Change from baseline at Cycle 4 Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0037
Change from baseline at Cycle 5 Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Change from baseline at Cycle 6 Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Change from baseline at Cycle 7 Day 1
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0035
OG002
Zilurgisertib Monotherapy 200 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 200 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG003
Zilurgisertib Monotherapy 400 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 400 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG004
Zilurgisertib Monotherapy 600 mg QD
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 600 mg administered as monotherapy QD. Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG005
Zilurgisertib Monotherapy 300 mg BID
Participants who were previously treated with JAK inhibitors for at least 12 weeks and were resistant, refractory, or lost response to a JAK inhibitor; or were intolerant to JAK inhibitor treatment; or were not eligible to receive JAK inhibitor treatment received zilurgisertib 300 mg administered as monotherapy twice daily (BID). Zilurgisertib was administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG006
Zilurgisertib 100 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 100 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG007
Zilurgisertib 200 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 200 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG008
Zilurgisertib 400 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG009
Zilurgisertib 600 mg QD + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 600 mg QD administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG010
Zilurgisertib 300 mg BID + Ruxolitinib, Add on to Ruxolitinib
Participants who had been on a stable dose of ruxolitinib for at least 12 weeks received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants received the combination of zilurgisertib plus ruxolitinib on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG011
Zilurgisertib 400 mg QD + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 400 mg QD administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
OG012
Zilurgisertib 300 mg BID + Ruxolitinib, JAK naïve
JAK inhibitor-naive participants with an indication for ruxolitinib initiation for MF-related symptoms received zilurgisertib 300 mg BID administered in a combination regimen with ruxolitinib. Participants started to receive zilurgisertib + ruxolitinib concurrently on Cycle 1 Day 1. Zilurgisertib and ruxolitinib were administered to the study participants as long as they benefitted from study treatment and they did not present any study treatment discontinuation criterion as per investigator's assessment for up to 12 months of treatment.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG00311
OG0044
OG0053
OG0064
OG0078
OG00812
OG0097
OG0106
OG0117
OG0128
Title
Denominators
Categories
Baseline
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00311
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG00812
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0128
Title
Measurements
OG00080.5417± 7.44657
OG00173.8750± 7.97261
OG00275.8413± 8.80063
OG003
Change from baseline at the end of treatment
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0133 events3 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0062 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0134 events3 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0133 events2 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0133 events2 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
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EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0132 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0133 events2 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0132 events2 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected8 at risk
EG0131 events1 affected84 at risk
25.0
(0.6 to 80.6)
OG0040.0(0.0 to 70.8)
OG0050.0(0.0 to 84.2)
OG00633.3(0.8 to 90.6)
OG0070.0(0.0 to 45.9)
OG0080.0(0.0 to 41.0)
OG0090.0(0.0 to 45.9)
OG0110.0(0.0 to 60.2)
OG0120.0(0.0 to 97.5)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
Title
Measurements
OG0000.0(0.0 to 97.5)
OG0010.0(0.0 to 84.2)
OG0020.0(0.0 to 84.2)
OG0030.0(0.0 to 60.2)
OG0070.0(0.0 to 97.5)
OG0100.0(0.0 to 70.8)
OG0110.0(0.0 to 97.5)
OG0120.0(0.0 to 70.8)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
81.97
± 8.161
OG00478.31± 4.064
OG00585.34± 6.209
OG00682.94± 4.293
OG00785.39± 5.155
OG00877.73± 10.765
OG00981.28± 14.185
OG01082.81± 9.712
OG01181.72± 12.980
OG01280.86± 8.950
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG0089
ParticipantsOG0096
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0124
Title
Measurements
OG0000.69± 5.384
OG0012.79± 2.837
OG00213.28± 18.581
OG00311.18± 9.276
OG004-5.50± 1.768
OG0051.55± NAStandard deviation was not calculated for a single participant.
OG00613.57± 12.594
OG0077.89± 7.487
OG0083.30± 7.152
OG0090.20± 9.470
OG0100.47± 3.192
OG0111.31± 11.030
OG0126.82± 14.118
1880
± 46
OG0042720± 49
OG0051570± 41
OG006277± 21
OG007776± 31
OG0082150± 45
OG0092700± 35
OG0101050± 22
OG0112220± 27
OG0121070± 56
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG00810
ParticipantsOG0095
ParticipantsOG0105
ParticipantsOG0116
ParticipantsOG0127
Title
Measurements
OG000265± 46
OG001756± 46
OG0021650± 59
OG0033650± 44
OG0045410± 33
OG0055914± 117.7
OG006548± 18
OG0071660± 28
OG0084690± 29
OG0094890± 29
OG0105040± 21
OG0113760± 38
OG0123510± 39
2.0
(1.9 to 6.0)
OG0042.0(2.0 to 2.2)
OG0052.1(2.0 to 2.1)
OG0062.1(2.0 to 6.0)
OG0072.0(1.9 to 2.0)
OG0082.1(1.8 to 6.3)
OG0092.0(1.8 to 4.1)
OG0102.0(1.8 to 4.2)
OG0112.0(1.9 to 2.1)
OG0122.0(1.8 to 6.0)
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG00810
ParticipantsOG0095
ParticipantsOG0105
ParticipantsOG0117
ParticipantsOG0126
Title
Measurements
OG0003.0(2.0 to 4.3)
OG0013.0(2.0 to 4.0)
OG0022.0(2.0 to 2.4)
OG0032.1(2.0 to 4.1)
OG0044.0(2.0 to 6.1)
OG0053.17(2.25 to 4.08)
OG0062.0(2.0 to 4.0)
OG0072.0(1.9 to 2.1)
OG0082.0(1.9 to 6.2)
OG0094.0(2.0 to 6.0)
OG0102.1(1.9 to 4.0)
OG0114.0(2.1 to 6.1)
OG0124.2(1.7 to 6.0)
7920
± 47
OG00411100± 52
OG0057050± 44
OG0061190± 14
OG0073370± 32
OG0088540± 44
OG00911800± 47
OG0104630± 26
OG0118700± 25
OG0124450± 51
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG00810
ParticipantsOG0095
ParticipantsOG0105
ParticipantsOG0116
ParticipantsOG0127
Title
Measurements
OG0001320± 51
OG0014060± 47
OG0028430± 62
OG00318200± 48
OG00428200± 35
OG00531041± 121.6
OG0062830± 19
OG0078280± 25
OG00823200± 26
OG00923700± 28
OG01026900± 25
OG01118700± 35
OG01219100± 41
783.52
± 943.008
OG004848.25± 710.500
OG005948.33± 1478.431
OG006922.00± 929.389
OG0071257.71± 1020.405
OG0081434.75± 1221.478
OG009803.21± 869.034
OG0101279.67± 1279.739
OG011349.64± 460.983
OG0121395.00± 1358.760
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG00812
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0128
Title
Measurements
OG000-387.00± 733.237
OG001-136.00± 162.872
OG002-193.54± 238.733
OG003-75.22± 215.427
OG004-62.25± 221.398
OG00578.67± 120.583
OG006-6.75± 86.257
OG00727.57± 423.474
OG008512.99± 634.485
OG009143.79± 249.883
OG010-283.83± 680.065
OG011-3.66± 30.719
OG01255.01± 130.317
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG00810
ParticipantsOG0097
ParticipantsOG0105
ParticipantsOG0117
ParticipantsOG0128
Title
Measurements
OG000-562.67± 1012.395
OG00194.50± 204.216
OG002-51.04± 472.136
OG003-133.00± 256.944
OG004-162.33± 441.681
OG005-212.67± 369.067
OG00667.50± 119.734
OG007-47.81± 638.348
OG00860.36± 273.778
OG009108.07± 309.080
OG010-348.60± 818.076
OG01116.56± 91.145
OG012-119.03± 265.654
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG00811
ParticipantsOG0097
ParticipantsOG0104
ParticipantsOG0117
ParticipantsOG0127
Title
Measurements
OG000-584.33± 1480.397
OG001-34.75± 262.646
OG002-137.30± 384.663
OG003-9.67± 251.892
OG004-219.25± 252.500
OG005-69.67± 103.963
OG00642.50± 59.220
OG007125.56± 462.871
OG008174.73± 613.536
OG009-19.93± 109.773
OG010-187.00± 507.240
OG011-6.26± 105.580
OG012-211.01± 500.281
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG00810
ParticipantsOG0097
ParticipantsOG0105
ParticipantsOG0117
ParticipantsOG0127
Title
Measurements
OG000132.25± 921.734
OG00146.25± 195.162
OG00228.65± 490.325
OG003-134.00± 390.617
OG004-38.25± 328.489
OG005-15.50± 2.121
OG00626.25± 101.082
OG007313.98± 1063.086
OG008160.35± 544.736
OG0096.49± 67.104
OG010586.80± 978.559
OG011-8.46± 100.535
OG012-207.06± 444.951
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG0088
ParticipantsOG0097
ParticipantsOG0105
ParticipantsOG0117
ParticipantsOG0127
Title
Measurements
OG000-139.00± 1074.912
OG00160.25± 211.308
OG002-2.85± 303.525
OG003-290.76± 573.227
OG004-137.75± 178.662
OG0059.00± 8.485
OG006-5.50± 108.966
OG0071049.63± 3153.244
OG00874.50± 575.764
OG00947.93± 140.124
OG010-315.00± 656.309
OG011-25.61± 141.763
OG012-278.92± 501.258
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0105
ParticipantsOG0117
ParticipantsOG0124
Title
Measurements
OG000115.00± 703.507
OG001-130.00± 57.347
OG002-34.22± 548.706
OG003-318.13± 631.468
OG004-442.00± 219.203
OG005-16.00± 2.828
OG006-56.25± 87.979
OG00782.79± 830.401
OG008163.54± 909.721
OG009-92.36± 202.697
OG010-65.00± 519.876
OG01119.64± 99.709
OG012-121.15± 488.252
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG0089
ParticipantsOG0096
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0123
Title
Measurements
OG000-1412.00± 2768.982
OG001-56.50± 115.072
OG00280.90± 717.345
OG003-300.71± 492.169
OG004-567.50± 341.533
OG005-21.00± NAStandard deviation was not calculated for a single participant.
OG006-78.75± 90.046
OG007-319.38± 481.083
OG00897.84± 521.617
OG00931.42± 143.390
OG010720.75± 1580.413
OG01183.98± 146.949
OG012-731.33± 857.439
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0116
ParticipantsOG0123
Title
Measurements
OG000-501.67± 885.455
OG00130.75± 146.067
OG002-338.43± 393.411
OG003-251.10± 469.071
OG004-287.00± NAStandard deviation was not calculated for a single participant.
OG005-40.00± NAStandard deviation was not calculated for a single participant.
OG00634.25± 130.321
OG007-243.00± 819.451
OG008313.25± 1168.777
OG009108.23± 248.601
OG010-121.33± 701.522
OG011201.05± 300.220
OG012-1006.60± 1272.523
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0114
ParticipantsOG0123
Title
Measurements
OG000-463.33± 928.219
OG00148.75± 196.366
OG002-364.63± 567.918
OG003-305.63± 728.881
OG004-295.00± NAStandard deviation was not calculated for a single participant.
OG005-42.00± NAStandard deviation was not calculated for a single participant.
OG006274.75± 632.836
OG007-134.31± 878.678
OG008-240.74± 672.545
OG009157.73± 456.747
OG01017.33± 453.715
OG011241.45± 391.095
OG012-886.17± 1359.140
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0085
ParticipantsOG0092
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
Title
Measurements
OG000607.50± 1202.789
OG00158.00± 161.470
OG002-92.55± 111.086
OG003-303.28± 494.640
OG004669.00± NAStandard deviation was not calculated for a single participant
OG005-32.00± NAStandard deviation was not calculated for a single participant
OG006-34.67± 43.190
OG00729.92± 926.584
OG008-209.16± 608.632
OG009-12.50± 31.820
OG010-578.00± 118.874
OG011411.20± 487.835
OG012-1168.40± 1530.772
81.9664
± 8.16128
OG00478.3125± 4.06394
OG00585.3444± 6.20934
OG00682.9375± 4.29328
OG00785.3890± 5.15479
OG00877.7296± 10.76512
OG00981.2833± 14.18543
OG01082.8122± 9.71229
OG01181.7238± 12.98042
OG01280.8577± 8.94992
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG00811
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0125
Title
Measurements
OG000-4.6667± NAStandard deviation was not calculated for a single participant.