A Study of INCB050465 in Combination With Ruxolitinib in... | NCT02718300 | Trialant
NCT02718300
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
May 1, 2024Actual
Enrollment
74Actual
Phase
Phase 2
Conditions
MPN (Myeloproliferative Neoplasms)
Interventions
Parsaclisib
Parsaclisib
Ruxolitinib
Parsaclisib
Parsaclisib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02718300
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 50465-201
Secondary IDs
ID
Type
Description
Link
Parsaclisib
Other Identifier
Incyte Corporation
Brief Title
A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Official Title
A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Expanded Access Info
YesNCT03147742Approved for marketing
Start Date
Feb 8, 2017Actual
Primary Completion Date
Jan 28, 2021Actual
Completion Date
Apr 29, 2022Actual
First Submitted Date
Mar 21, 2016
First Submission Date that Met QC Criteria
Mar 23, 2016
First Posted Date
Mar 24, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 10, 2024
Results First Submitted that Met QC Criteria
Apr 2, 2024
Results First Posted Date
May 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 12, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 1, 2024Actual
Last Update Submitted Date
Apr 2, 2024
Last Update Posted Date
May 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
Drug: Parsaclisib
Drug: Ruxolitinib
Part 2: Ruxolitinib + Parsaclisib
Experimental
Part 2 will compare 2 doses of parsaclisib .
Drug: Parsaclisib
Drug: Ruxolitinib
Part 3: Ruxolitinib + Parsaclisib
Experimental
Part 3 will compare 2 different long term dosing strategies.
Drug: Ruxolitinib
Drug: Parsaclisib
Part 4: Ruxolitinib + Parsaclisib
Experimental
Part 4 will compare 2 different daily dosing strategies.
Drug: Ruxolitinib
Drug: Parsaclisib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Parsaclisib
Drug
Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
Part 1: Ruxolitinib + Parsaclisib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were defined as the occurrence of any protocol-defined toxicities occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression, other medications) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria.
up to Day 28
Change From Baseline in Spleen Volume Through Week 12 of the Initial Study Period as Measured by Magnetic Resonance Imaging (MRI) (or Computed Tomography [CT] Scan in Applicable Participants)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 12
Percent Change From Baseline in Spleen Volume Through Week 12 as Measured by MRI (or CT Scan in Applicable Participants)
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Spleen Volume Through Week 24 of the Initial Study Period as Measured by MRI (or CT Scan in Applicable Participants)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 24
Percent Change From Baseline in Spleen Volume Through Week 24 as Measured by MRI (or CT Scan in Applicable Participants )
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria:
Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
Unwillingness to be transfused with blood components
Recent history of inadequate bone marrow reserve as demonstrated by the following:
Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening
Subjects with peripheral blood blast count of > 10% at the screening or baseline hematology assessments
Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels
Inadequate liver function at screening as demonstrated by the following:
Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
Yacoub A, Borate U, Rampal RK, Ali H, Wang ES, Gerds AT, Hobbs G, Kremyanskaya M, Winton E, O'Connell C, Goel S, Oh ST, Schiller G, McCloskey J, Palmer J, Holmes H, Hager S, Assad A, Erickson-Viitanen S, Zhou F, Daver N. Phase 2 study of add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: final results. Blood Adv. 2024 Mar 26;8(6):1515-1528. doi: 10.1182/bloodadvances.2023011620.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study was conducted at 20 study centers in the United States. Participants who initially received weekly doses were given the option of transitioning to daily doses based on a preliminary analysis of data. All participants were analyzed according to their original treatment assignment in the Participant Flow and Baseline Characteristic module; those participants who transitioned from weekly to daily doses (n=8) were analyzed separately for specific outcome measures.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Due to early termination of the study, per the Statistical Analysis Plan, participants were combined into arms based on the dosage received regardless of what phase of the study they participated in.
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 11, 2018
Jan 10, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
INCB050465
Parsaclisib
Drug
Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
Part 2: Ruxolitinib + Parsaclisib
INCB050465
Ruxolitinib
Drug
The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
Part 1: Ruxolitinib + Parsaclisib
Part 2: Ruxolitinib + Parsaclisib
Part 3: Ruxolitinib + Parsaclisib
Part 4: Ruxolitinib + Parsaclisib
Jakafi®
Parsaclisib
Drug
20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
Part 3: Ruxolitinib + Parsaclisib
INCB050465
Parsaclisib
Drug
2 dose strategies will be compared:
5 mg parsaclisib beginning on Day 1 until end of treatment.
20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.
Part 4: Ruxolitinib + Parsaclisib
INCB050465
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 24
Change From Baseline in the Total Symptom Score (TSS) Through Week 12 as Measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 3.0 (v3.0) Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Baseline; Week 12
Percent Change From Baseline in the TSS Through Week 12 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 12
Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Baseline; Week 24
Percent Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 24
Change From Baseline in the TSS Through Week 12 as Measured by Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Baseline; Week 12
Percent Change From Baseline in the TSS Through Week 12 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 12
Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Baseline; Week 24
Percent Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Baseline; Week 24
Number of Participants With the Indicated Patient Global Impression of Change (PGIC) Score at Week 12, Week 24, and the End of Treatment (EOT)
The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."
Baseline; up to 1494 days (EOT)
Mean PGIC Score at Week 12, Week 24, and the EOT
The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."
up to 1494 days (EOT)
Best Overall Response (Percentage of Participants With Complete Response [CR] or Partial Response [PR]) for Investigator-Reported International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Response Assessment
A participant was considered as a responder if the participant had a best overall response of CR or PR. CR: (a) bone marrow (BM): age-adjusted normocellularity (AAN); < 5% blasts; ≤ grade 1 myelofibrosis (MF); (b) peripheral blood (PD): hemoglobin (Hg) ≥ 100 grams per Liter (g/L) and < upper normal limit (UNL); neutrophils ≥ 1 × 10^9/L and < UNL; (c) platelets ≥ 100 × 10^9/L and < UNL; < 2% immature myeloid cells (IMCs); (d) clinical: resolution of disease symptoms; spleen/liver not palpable; no extramedullary hematopoiesis (EMH). PR: (a) PB: Hg ≥ 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 100 × 10^9/L and < UNL; < 2% IMCs; (b) clinical: resolution of disease symptoms; spleen/liver not palpable; no EMH; (c) BM: AAN; < 5% blasts; ≤ Grade 1 MF; and PB: Hg ≥ 85 g/L but < 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 50 × 10^9/L but < 100 × 10^9/L and < UNL; < 2% IMCs.
Week 12 and every 12 weeks thereafter (up to 1494 days [EOT])
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug.
up to approximately 4 years
Number of Participants With Any TEAE During the Transition Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug. Participants who had been assigned to dosing arms with weekly dosing beyond Week 8 had the opportunity to transition to all daily dosing at 5 mg if agreed upon by the participant and the Investigator.
up to approximately 4 years
Cmax of Parsaclisib
Cmax was defined as the maximum observed plasma concentration.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Tmax of Parsaclisib
tmax was defined as the time to the maximum concentration.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmin of Parsaclisib
Cmin was defined as the minimum observed plasma concentration.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-4h of Parsaclisib
AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-t of Parsaclisib
AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Clast of Parsaclisib
Clast was defined as the last quantifiable concentration.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Tlast of Parsaclisib
tlast was defined as the time of the last quantifiable concentration.
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmax of Ruxolitinib
Cmax was defined as the maximum observed plasma concentration.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Tmax of Ruxolitinib
tmax was defined as the time to the maximum concentration.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmin of Ruxolitinib
Cmin was defined as the minimum observed plasma concentration.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-4h of Ruxolitinib
AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-t of Ruxolitinib
AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Clast of Ruxolitinib
Clast was defined as the last quantifiable concentration.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Tlast of Ruxolitinib
tlast was defined as the time of the last quantifiable concentration.
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Scottsdale
Arizona
85259
United States
Alta Bates Medical Center
Berkeley
California
94704
United States
City of Hope National Medical Center
Duarte
California
91010
United States
California Cancer Associates For Research and Excellence
Fresno
California
93720
United States
University of Southern California
Los Angeles
California
90033
United States
UCLA School of Medicine
Los Angeles
California
90095
United States
Pcr Oncology
Pismo Beach
California
93449
United States
California Cancer Assoc. for Research and Excellence
San Marcos
California
92069
United States
Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
Shands Hospital
Gainesville
Florida
32610
United States
Emory University
Atlanta
Georgia
30322
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Indiana Blood and Marrow Transplantation
Indianapolis
Indiana
46237
United States
McFarland Clinic
Ames
Iowa
50010
United States
University of Kansas Cancer Center
Westwood
Kansas
66205
United States
Norton Cancer Institute
Louisville
Kentucky
40202
United States
Saint Agnes Hospital
Baltimore
Maryland
21229
United States
Cancer Center For Blood Disorders
Bethesda
Maryland
20817
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Washington University School of Medicine
St Louis
Missouri
63130
United States
Summit Medical Group
Florham Park
New Jersey
07932
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
New Mexico Cancer Care Alliance
Albuquerque
New Mexico
87106
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Mount Sinai School of Medicine
New York
New York
10029
United States
Columbia University Medical Center
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
Oncology Hematology Care, Inc.
Cincinnati
Ohio
45230
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Rush University Medical Center
Nashville
Tennessee
37203
United States
Baylor Scott and White Research Institute
Dallas
Texas
75246
United States
Md Anderson Cancer Center
Houston
Texas
77030
United States
Cancer Care Centers of South Texas
San Antonio
Texas
78217
United States
Renovatio Clinical Consultants Llc
The Woodlands
Texas
77380
United States
Va Salt Lake City Health Care System
Salt Lake City
Utah
84112
United States
Vista Oncology Inc Ps
Olympia
Washington
98506
United States
FG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
FG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
FG00021 subjects
FG00121 subjects
FG00232 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00021 subjects
FG00121 subjects
FG00232 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0015 subjects
FG00217 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
Study Terminated by Sponsor
FG0006 subjects
FG0013 subjects
FG0024 subjects
Withdrawal by Subject
FG0000 subjects
FG0014 subjects
FG0023 subjects
Transitioned to Rollover Study or Pursued Allogenic Transplant
FG0009 subjects
FG0019 subjects
FG0024 subjects
Due to early termination of the study, per the Statistical Analysis Plan, participants were combined into arms based on the dosage received regardless of what phase of the study they participated in.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
BG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
BG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00121
BG00232
BG00374
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
BG00067.9± 7.33
BG00169.3± 7.96
BG00266.0± 8.94
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00020
BG00115
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 Dose-limiting Toxicities (DLTs)
DLTs were defined as the occurrence of any protocol-defined toxicities occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression, other medications) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria.
Initial Safety Population: all participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study drug treatment. Analysis was conducted on the Safety Population during the initial safety period. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for analysis.
Posted
Count of Participants
Participants
up to Day 28
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00021
OG00121
OG00232
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Primary
Change From Baseline in Spleen Volume Through Week 12 of the Initial Study Period as Measured by Magnetic Resonance Imaging (MRI) (or Computed Tomography [CT] Scan in Applicable Participants)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Initial Safety Population: all enrolled participants who received at least 1 dose of study drug. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
centimeters cubed (cm^3)
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Primary
Percent Change From Baseline in Spleen Volume Through Week 12 as Measured by MRI (or CT Scan in Applicable Participants)
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Change From Baseline in Spleen Volume Through Week 24 of the Initial Study Period as Measured by MRI (or CT Scan in Applicable Participants)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
cm^3
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Percent Change From Baseline in Spleen Volume Through Week 24 as Measured by MRI (or CT Scan in Applicable Participants )
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Change From Baseline in the Total Symptom Score (TSS) Through Week 12 as Measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 3.0 (v3.0) Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
scores on a scale
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Percent Change From Baseline in the TSS Through Week 12 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
scores on a scale
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Percent Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary
The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Change From Baseline in the TSS Through Week 12 as Measured by Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
scores on a scale
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Percent Change From Baseline in the TSS Through Week 12 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 12
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
Secondary
Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
scores on a scale
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
Secondary
Percent Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF
The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
percent change
Baseline; Week 24
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
Secondary
Number of Participants With the Indicated Patient Global Impression of Change (PGIC) Score at Week 12, Week 24, and the End of Treatment (EOT)
The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Count of Participants
Participants
Baseline; up to 1494 days (EOT)
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Mean PGIC Score at Week 12, Week 24, and the EOT
The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Only participants with available data were analyzed. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Mean
Standard Deviation
scores on a scale
up to 1494 days (EOT)
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Best Overall Response (Percentage of Participants With Complete Response [CR] or Partial Response [PR]) for Investigator-Reported International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Response Assessment
A participant was considered as a responder if the participant had a best overall response of CR or PR. CR: (a) bone marrow (BM): age-adjusted normocellularity (AAN); < 5% blasts; ≤ grade 1 myelofibrosis (MF); (b) peripheral blood (PD): hemoglobin (Hg) ≥ 100 grams per Liter (g/L) and < upper normal limit (UNL); neutrophils ≥ 1 × 10^9/L and < UNL; (c) platelets ≥ 100 × 10^9/L and < UNL; < 2% immature myeloid cells (IMCs); (d) clinical: resolution of disease symptoms; spleen/liver not palpable; no extramedullary hematopoiesis (EMH). PR: (a) PB: Hg ≥ 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 100 × 10^9/L and < UNL; < 2% IMCs; (b) clinical: resolution of disease symptoms; spleen/liver not palpable; no EMH; (c) BM: AAN; < 5% blasts; ≤ Grade 1 MF; and PB: Hg ≥ 85 g/L but < 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 50 × 10^9/L but < 100 × 10^9/L and < UNL; < 2% IMCs.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for efficacy analysis.
Posted
Number
percentage of participants
Week 12 and every 12 weeks thereafter (up to 1494 days [EOT])
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug.
Initial Safety Population. Analysis was conducted on the Safety Population during the initial safety period. Due to early termination of the study, per the Statistical Analysis Plan, daily and weekly dosing arms were combined for analysis.
Posted
Count of Participants
Participants
up to approximately 4 years
ID
Title
Description
OG000
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG001
TG5D
Secondary
Number of Participants With Any TEAE During the Transition Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug. Participants who had been assigned to dosing arms with weekly dosing beyond Week 8 had the opportunity to transition to all daily dosing at 5 mg if agreed upon by the participant and the Investigator.
Transition Safety Population. AEs were reported in the initial randomization group (TG10, TG20) if the start of the AEs occurred before transitioning to TG5D. If the start of the AEs occurred after transitioning to TG5D, they were reported in the TG5D Transition arm.
Posted
Count of Participants
Participants
up to approximately 4 years
ID
Title
Description
OG000
TG5D Transition
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. Participants randomized to receive oral parsaclisib 10 mg or 20 mg QD from Day 1 to the end of Week 8 transitioned to oral parsaclisib 5 mg QD after Week 8. Transition participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Secondary
Cmax of Parsaclisib
Cmax was defined as the maximum observed plasma concentration.
Pharmacokinetic (PK) Population: all treated participants who contributed plasma PK samples. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomoles per Liter (nmol/L)
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
Tmax of Parsaclisib
tmax was defined as the time to the maximum concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Median
Full Range
hours
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Secondary
Cmin of Parsaclisib
Cmin was defined as the minimum observed plasma concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
AUC0-4h of Parsaclisib
AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours * nmol/L
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
AUC0-t of Parsaclisib
AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x nmol/L
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
Clast of Parsaclisib
Clast was defined as the last quantifiable concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
Tlast of Parsaclisib
tlast was defined as the time of the last quantifiable concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the dose of parsaclisib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg
Participants in TG5I/M received oral parsaclisib 5 mg QD from Week 8 until discontinuation criteria were met. Participants in TG5D received oral parsaclisib 5 mg QD until discontinuation criteria were met. Participants in TG10 and TG20 who were randomized to receive oral parsaclisib 10 mg or 20 mg QD transitioned to oral parsaclisib 5 mg QD after Week 8.
OG001
Parsaclisib 10 mg
Participants in TG10 received oral parsaclisib 10 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 10 mg QD for 8 weeks but transitioned to oral parsaclisib 5 mg QD after Week 8.
OG002
Parsaclisib 20 mg
Secondary
Cmax of Ruxolitinib
Cmax was defined as the maximum observed plasma concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Secondary
Tmax of Ruxolitinib
tmax was defined as the time to the maximum concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Median
Full Range
hours
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Secondary
Cmin of Ruxolitinib
Cmin was defined as the minimum observed plasma concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Secondary
AUC0-4h of Ruxolitinib
AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x nmol/L
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Secondary
AUC0-t of Ruxolitinib
AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x nmol/L
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Secondary
Clast of Ruxolitinib
Clast was defined as the last quantifiable concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Secondary
Tlast of Ruxolitinib
tlast was defined as the time of the last quantifiable concentration.
PK Population. Only participants with available data were analyzed. To be able to form a meaningful statistical test with enough participants, participants across all treatment groups were combined according to the pre-Day 1 stable dose of ruxolitinib received for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
ID
Title
Description
OG000
Ruxolitinib 5 mg
Throughout the study, participants received a stable dose of ruxolitinib 5 mg BID.
OG001
Ruxolitinib 10 mg
Throughout the study, participants received a stable dose of ruxolitinib 10 mg BID.
OG002
Ruxolitinib 15 mg
Throughout the study, participants received a stable dose of ruxolitinib 15 mg BID.
OG003
Ruxolitinib 20 mg
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
Time Frame
up to approximately 1529 days
Description
An AE was reported in the initial randomization group (TG10, TG20) if it started before transition to TG5D. An AE was reported in the TG5D Transition arm if it started after transition to TG5D. Due to early termination of the study, per the Statistical Analysis Plan, the 4 dosage groups (TG10: Daily/Weekly Dosing; TG20: Daily/Weekly Dosing; TG5I/M; TG5D), as well as the participants who transitioned from daily/weekly to all-daily dosing (TG5D Transition), were compared separately for safety.
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
TG10: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 10 milligrams (mg) once daily (QD), followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
6
14
2
14
13
14
EG001
TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg QD, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
11
18
11
18
18
18
EG002
TG5I/M
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 milligrams (mg) twice a day (BID) to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants received oral parsaclisib 20 mg once daily (QD), followed by 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
4
21
7
21
20
21
EG003
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
5
21
6
21
20
21
EG004
Total: Initially Randomized Participants
Total
26
74
26
74
71
74
EG005
TG5D Transition
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. Participants randomized to receive oral parsaclisib 10 mg or 20 mg QD from Day 1 to the end of Week 8 transitioned to oral parsaclisib 5 mg QD after Week 8. Transition participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
3
8
3
8
8
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected21 at risk
EG0041 events1 affected74 at risk
EG0050 events0 affected8 at risk
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blast crisis in myelogenous leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0013 events3 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Splenic haematoma
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Splenic haemorrhage
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Tobacco withdrawal symptoms
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Troponin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Withdrawal syndrome
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG0030 events0 affected21 at risk
EG0042 events2 affected74 at risk
EG0051 events1 affected8 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG0014 events3 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0015 events4 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0014 events3 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0013 events3 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0016 events5 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0014 events3 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0005 events2 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0016 events4 affected18 at risk
EG0023 events2 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0016 events6 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0019 events6 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0014 events3 affected18 at risk
EG0022 events1 affected21 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected14 at risk
EG0015 events3 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0014 events4 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0015 events5 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Early satiety
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events4 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Extramedullary haemopoiesis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Facial pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0016 events5 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0017 events7 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Feeling abnormal
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hernia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hyperalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0013 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Hyperplastic cholecystopathy
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0015 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0026 events6 affected21 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Morton's neuralgia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0024 events4 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG0017 events6 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Oral blood blister
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0013 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG00111 events5 affected18 at risk
EG0028 events2 affected21 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0017 events4 affected18 at risk
EG0023 events3 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0005 events3 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected14 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Streptococcal urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected14 at risk
EG0015 events5 affected18 at risk
EG00212 events6 affected21 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected14 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected14 at risk
EG0013 events2 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected21 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected14 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D030342
Genetic Diseases, Inborn
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000656179
parsaclisib
C540383
ruxolitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
67.5
± 8.25
17
BG00339
Male
BG00010
BG00110
BG00215
BG00335
3
BG0035
Not Hispanic or Latino
BG00018
BG00119
BG00227
BG00364
Unknown or Not Reported
BG0003
BG0010
BG0022
BG0035
25
BG00360
Black or African American
Title
Measurements
BG0001
BG0012
BG0020
BG0033
Asian
Title
Measurements
BG0000
BG0012
BG0023
BG0035
Captured as "Other" in Database
Title
Measurements
BG0000
BG0012
BG0024
BG0036
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00020
OG00117
OG00229
Title
Denominators
Categories
Baseline
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00229
Title
Measurements
OG0001779.0± 1006.75
OG0012032.3± 773.45
OG0022469.0± 1208.90
Change from Baseline at Week 12
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00228
Title
Measurements
OG000
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00020
OG00117
OG00228
Title
Denominators
Categories
Title
Measurements
OG0009.2± 104.37
OG001-15.2± 10.89
OG002-3.1± 12.21
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by ECOG Performance Status at Screening (0 or 1 versus 2)
0.4046
Superiority
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00020
OG00117
OG00229
Title
Denominators
Categories
Baseline
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00229
Title
Measurements
OG0001779.0± 1006.75
OG0012032.3± 773.45
OG0022469.0± 1208.90
Change from Baseline at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00220
Title
Measurements
OG000
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00015
OG00114
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-21.9± 24.10
OG001-19.0± 11.23
OG002-4.9± 18.81
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by ECOG Performance Status at Screening (0 or 1 versus 2)
0.7802
Superiority
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00016
OG00116
OG00228
Title
Denominators
Categories
Baseline
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00228
Title
Measurements
OG00017.6± 10.59
OG00116.3± 12.82
OG00215.2± 12.94
Change from Baseline at Week 12
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00222
Title
Measurements
OG000
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00012
OG00112
OG00221
Title
Denominators
Categories
Title
Measurements
OG000-37.0± 30.93
OG001-17.7± 57.81
OG00210.1± 118.94
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by ECOG Performance Status at Screening (0 or 1 versus 2)
0.6856
Superiority
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00016
OG00116
OG00228
Title
Denominators
Categories
Baseline
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00228
Title
Measurements
OG00017.6± 10.59
OG00116.3± 12.82
OG00215.2± 12.94
Change from Baseline at Week 24
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00217
Title
Measurements
OG000
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG0008
OG00110
OG00216
Title
Denominators
Categories
Title
Measurements
OG000-29.2± 41.08
OG001-16.7± 76.27
OG00211.1± 80.23
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by ECOG Performance Status at Screening (0 or 1 versus 2)
0.3385
Superiority
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00018
OG00119
OG00228
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00228
Title
Measurements
OG00030.0± 17.88
OG00127.7± 18.18
OG00229.2± 19.56
Change from Baseline at Week 12
ParticipantsOG00014
ParticipantsOG00116
ParticipantsOG00221
Title
Measurements
OG000
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00014
OG00116
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-28.7± 42.48
OG001-38.1± 44.76
OG002-20.1± 40.88
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)
0.4005
Superiority
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00018
OG00119
OG00228
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00228
Title
Measurements
OG00030.0± 17.88
OG00127.7± 18.18
OG00229.2± 19.56
Change from Baseline at Week 24
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00013
OG00113
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-63.4± 28.14
OG001-44.7± 38.07
OG002-35.9± 40.43
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Van Elteren test
stratified by ECOG Performance Status at Screening (0 or 1 versus 2)
0.3138
Superiority
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00021
OG00121
OG00232
Title
Denominators
Categories
Week 12, very much improved
Title
Measurements
OG0001
OG0011
OG0021
Week 12, much improved
Title
Measurements
OG0004
OG0014
OG0028
Week 12, minimally improved
Title
Measurements
OG0005
OG0016
OG0025
Week 12, no change
Title
Measurements
OG0006
OG0016
OG0026
Week 12, minimally worse
Title
Measurements
OG0002
OG0010
OG0023
Week 12, much worse
Title
Measurements
OG0000
OG0010
OG0021
Week 12, very much worse
Title
Measurements
OG0000
OG0010
OG0020
Week 12, not reported
Title
Measurements
OG0003
OG0014
OG0028
Week 24, very much improved
Title
Measurements
OG0001
OG0011
OG0023
Week 24, much improved
Title
Measurements
OG0007
OG0014
OG0029
Week 24, minimally improved
Title
Measurements
OG0004
OG0016
OG0024
Week 24, no change
Title
Measurements
OG0003
OG0011
OG0023
Week 24, minimally worse
Title
Measurements
OG0000
OG0011
OG0020
Week 24, much worse
Title
Measurements
OG0000
OG0010
OG0020
Week 24, very much worse
Title
Measurements
OG0000
OG0010
OG0020
Week 24, not reported
Title
Measurements
OG0006
OG0018
OG00213
EOT, very much improved
Title
Measurements
OG0000
OG0010
OG0021
EOT, much improved
Title
Measurements
OG0002
OG0016
OG0024
EOT, minimally improved
Title
Measurements
OG0007
OG0013
OG0021
EOT, no change
Title
Measurements
OG0004
OG0015
OG0023
EOT, minimally worse
Title
Measurements
OG0002
OG0011
OG0022
EOT, much worse
Title
Measurements
OG0001
OG0011
OG0022
EOT, very much worse
Title
Measurements
OG0000
OG0010
OG0021
EOT, not reported
Title
Measurements
OG0005
OG0015
OG00218
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00021
OG00121
OG00232
Title
Denominators
Categories
Week 12
ParticipantsOG00018
ParticipantsOG00117
ParticipantsOG00224
Title
Measurements
OG0003.2± 1.11
OG0013.0± 0.94
OG0023.2± 1.28
Week 24
ParticipantsOG00015
ParticipantsOG00113
ParticipantsOG00219
Title
Measurements
OG000
EOT
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00214
Title
Measurements
OG000
OG001
TG5D
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00021
OG00121
OG00232
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0019.5
OG0029.4
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1, participants received oral parsaclisib 5 mg QD until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
OG002
TG10 + TG20: Daily/Weekly Dosing
Participants received at least 6 months of prior ruxolitinib therapy, including ruxolitinib administration at a stable dose of 5 mg BID to 25 mg BID for at least 8 weeks before randomization. From Day 1 to the end of Week 8, participants in TG10 and TG20 received oral parsaclisib 10 mg or 20 mg QD, respectively, followed by the same dose weekly until discontinuation criteria were met, in combination with the pre-Day 1 stable dose of ruxolitinib (5 to 25 mg BID).
Units
Counts
Participants
OG00021
OG00121
OG00232
Title
Denominators
Categories
Title
Measurements
OG00020
OG00120
OG00231
Units
Counts
Participants
OG0008
Title
Denominators
Categories
Title
Measurements
OG0008
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG000350± 40.8
OG001734± 29.4
OG0021620± 31.6
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Week 2
ANOVA
0.3577
Superiority
OG000
OG001
Week 2
Geometric Mean Ratio (GMR)
1.048
2-Sided
95
0.791
1.388
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 2
GMR
1.159
2-Sided
95
0.936
1.435
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.1709
Superiority
OG000
OG001
Week 4
GMR
1.00
2-Sided
95
0.780
1.281
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
1.176
2-Sided
95
0.955
1.448
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG0001.0(0.8 to 3.8)
OG0011.0(1.0 to 2.0)
OG0021.0(0.8 to 3.9)
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Week 2
Kruskal-Wallis
0.6693
Superiority
OG000
Week 4
Kruskal-Wallis
0.1521
Superiority
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG00038.3± 64.7
OG00144.7± 106
OG002151± 60.5
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Week 2
ANOVA
0.0809
Superiority
OG000
OG001
Week 2
GMR
0.583
2-Sided
95
0.342
0.994
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 2
GMR
0.986
2-Sided
95
0.658
1.477
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.1525
Superiority
OG000
OG001
Week 4
GMR
1.062
2-Sided
95
0.604
1.867
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
1.504
2-Sided
95
0.937
2.414
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG000982± 39.4
OG0012000± 30.5
OG0024560± 30.3
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Week 2
ANOVA
0.2873
Superiority
OG000
OG001
Week 2
GMR
1.016
2-Sided
95
0.773
1.336
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 2
GMR
1.161
2-Sided
95
0.943
1.429
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.1601
Superiority
OG000
OG001
Week 4
GMR
0.992
2-Sided
95
0.773
1.274
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
1.177
2-Sided
95
0.955
1.452
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG000982± 39.4
OG0012000± 30.5
OG0024560± 30.3
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG000224± 31.6
OG001419± 24.0
OG002949± 30.1
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
Participants in TG5I/M recevied oral parsaclisib 20 mg QD for 8 weeks. Participants in TG20 received oral parsaclisib 20 mg QD for 8 weeks, followed by the same dose weekly until discontinuation criteria were met. Other participants were randomized to receive oral parsaclisib 20 mg QD for 8 weeks, then received 5 mg QD from Week 8 until discontinuation criteria were met.
Units
Counts
Participants
OG00015
OG00112
OG00228
Title
Denominators
Categories
Week 2
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00228
Title
Measurements
OG0003.89± 3.87
OG0013.96± 1.58
OG0023.94± 2.55
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00228
Title
Measurements
OG000
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG000202± 39.5
OG001491± 26.3
OG002579± 31.8
OG003760± 40.8
OG004875± 31.3
Week 4
Title
Measurements
OG000335± 53.9
OG001471± 37.6
OG002704± 34.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Day 1
ANOVA
0.0830
Superiority
OG000
OG001
Day 1
GMR
1.218
2-Sided
95
0.846
1.753
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Day 1
GMR
0.957
2-Sided
95
0.654
1.399
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Day 1
GMR
0.943
2-Sided
95
0.656
1.354
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Day 1
GMR
0.867
2-Sided
95
0.579
1.298
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.2402
Superiority
OG000
OG001
Week 4
GMR
0.702
2-Sided
95
0.461
1.069
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
0.700
2-Sided
95
0.456
1.073
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Week 4
GMR
0.638
2-Sided
95
0.428
0.951
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Week 4
GMR
0.627
2-Sided
95
0.397
0.990
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001.1(0.9 to 2.0)
OG0011.0(0.5 to 2.0)
OG0021.0(0.8 to 1.0)
OG0031.0(0.8 to 2.0)
OG0041.0(1.0 to 1.9)
Week 4
Title
Measurements
OG0001.0(0.9 to 1.0)
OG0011.0(0.8 to 1.9)
OG0021.0(0.8 to 2.0)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Day 1
Kruskal-Wallis
0.0756
Superiority
OG000
Week 4
Kruskal-Wallis
0.0866
Superiority
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG0009.23± 141
OG00123.5± 122
OG00228.7± 226
OG00325.9± 263
OG00424.2± 156
Week 4
Title
Measurements
OG00011.1± 178
OG00119.5± 269
OG00240.7± 187
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Day 1
ANOVA
0.4287
Superiority
OG000
OG001
Day 1
GMR
1.272
2-Sided
95
0.329
4.914
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Day 1
GMR
1.036
2-Sided
95
0.252
4.251
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Day 1
GMR
0.702
2-Sided
95
0.180
2.731
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Day 1
GMR
0.525
2-Sided
95
0.118
2.348
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.9788
Superiority
OG000
OG001
Week 4
GMR
0.879
2-Sided
95
0.198
3.896
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
1.225
2-Sided
95
0.270
5.560
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Week 4
GMR
0.918
2-Sided
95
0.221
3.821
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Week 4
GMR
0.853
2-Sided
95
0.169
4.299
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG000440± 39.7
OG0011100± 25.5
OG0021310± 35.8
OG0031700± 52.4
OG0041890± 23.4
Week 4
Title
Measurements
OG000718± 67.9
OG0011090± 29.5
OG0021730± 38.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Day 1
ANOVA
0.1208
Superiority
OG000
OG001
Day 1
GMR
1.251
2-Sided
95
0.832
1.879
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Day 1
GMR
0.992
2-Sided
95
0.649
1.518
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Day 1
GMR
0.967
2-Sided
95
0.645
1.450
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Day 1
GMR
0.860
2-Sided
95
0.548
1.350
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
Week 4
ANOVA
0.3218
Superiority
OG000
OG001
Week 4
GMR
0.761
2-Sided
95
0.482
1.200
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG002
Week 4
GMR
0.803
2-Sided
95
0.506
1.277
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG003
Week 4
GMR
0.667
2-Sided
95
0.432
1.028
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
OG000
OG004
Week 4
GMR
0.640
2-Sided
95
0.390
1.051
ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.
Superiority
Throughout the study, participants received a stable dose of ruxolitinib 20 mg BID.
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG000440± 39.7
OG0011100± 25.5
OG0021310± 35.8
OG0031700± 52.4
OG0041890± 23.4
Week 4
Title
Measurements
OG000718± 67.9
OG0011090± 29.5
OG0021730± 38.9
OG003
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.
Units
Counts
Participants
OG0004
OG00118
OG00212
OG00319
OG0048
Title
Denominators
Categories
Day 1
Title
Measurements
OG00053.0± 60.4
OG001145± 38.2
OG002213± 64.1
OG003233± 109
OG004235± 38.8
Week 4
Title
Measurements
OG00087.1± 111
OG001156± 36.4
OG002285± 58.7
OG003
OG004
Ruxolitinib 25 mg
Throughout the study, participants received a stable dose of ruxolitinib 25 mg BID.