Polycythemia Vera
Conditions
Keywords
polycythemia vera, PV, P vera, myeloproliferative diseases, hematologic diseases, myeloproliferative neoplasm, MPN
Brief summary
This is an open-label, single-arm study of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV). The study will include two phases: initial phase and expansion phase. The initial phase will assess the safety and efficacy of idasanutlin monotherapy in ruxolitinib naïve and ruxolitinib-resistant or intolerant patients, respectively. If the initial phase shows promising results for ruxolitinib-resistant or intolerant patients, an expansion phase will be opened to further characterize the efficacy of idasanutlin.
Interventions
DRUGIdasanutlin
All participants will receive 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years). Intra-participant dose-escalation to 200 mg daily for 5 days may be permitted after Cycle 3 for those who demonstrate no hematocrit (Hct) control and/or for those with inadequately controlled leukocytosis and/or thrombocytosis in which the investigator judges that better control is important.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documentation that the participant has met the revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera (PV) * Hematocrit at screening and at initiation of idasanutlin greater than (\>)40% * Phlebotomy-dependent participants with splenomegaly by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging (greater than or equal to \[≥\]450 cubic centimeters \[cm\^3\]) or without splenomegaly (less than \[\<\]450 cm\^3 or prior splenectomy) * Resistance to/intolerance to hydroxyurea according to modified European Leukemia Net (ELN) criteria * For participants in the ruxolitinib intolerant or resistant group, in addition to previous hydroxyurea intolerance/resistance: Therapy-resistant PV after at least 6 months of treatment with ruxolitinib, as defined in the protocol; Ruxolitinib intolerance, as defined in the protocol; and Documentation of adverse events likely caused by ruxolitinib (assessment of attending physician) and that are of a severity that preclude further treatment with ruxolitinib (as per judgment of the attending physician and the patient) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants must be willing to submit the blood sampling and bone marrow sampling for the pharmacokinetic (PK) and pharmacodynamic analyses and exploratory biomarkers * Adequate hepatic and renal function * Ability and willingness to comply with the study protocol procedures, including clinical outcome assessment measures * For women of childbearing potential: agreement to use contraceptive methods that result in a failure rate of less than (\<)1% per year during the treatment period and for at least 6 weeks after the last dose of idasanutlin * For men: Agreement to use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 90 days after the last dose of idasanutlin
Exclusion criteria
* Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) * Blast phase disease (\>20% blasts in the marrow or peripheral blood) * Clinically-significant thrombosis within 3 months of screening * Participants who must receive CYP2C8 inhibitors, substrates and inducers, strong CYP3A4 inducers, or OATP1B1/3 substrates while on study. These must be discontinued 7 days (inhibitors and substrates) or 14 days (inducers) prior to start of study medication * Previously treated with murine double minute 2 (MDM2) antagonist therapies or receiving interferon-alpha, anagrelide, or ruxolitinib within 28 days or 5 half-lives (whichever is shorter), or hydroxyurea within 1 day, or receiving any other cytoreductive or investigational agents within 28 days or 5 half-lives (whichever is shorter) of initial dose. Aspirin is permitted per treatment guidelines for PV unless medically contraindicated * Patients with evidence of electrolyte imbalance such as hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, and hypermagnesemia of Grade \>1 intensity, as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, prior to dosing on Cycle 1 Day 1. Treatment for correction of electrolyte imbalances is permitted to meet eligibility * Neutrophil count \<1.5 × 10\^9/Liter (L) prior to dosing on Cycle 1 Day 1 * Platelet count less than or equal to (≤)150 × 10\^9/L prior to dosing on Cycle 1 Day 1 * Women who are pregnant or breastfeeding * Ongoing serious non-healing wound, ulcer, or bone fracture * History of major organ transplant * Uncontrolled intercurrent illness including, but not limited to hepatitis, concurrent malignancy that could affect compliance with the protocol or interpretation of results, hepatitis A, B, and C, human immunodeficiency virus (HIV)-positive, ongoing or active infection, clinically significant cardiac disease (New York Heart Association Class III or IV), symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Concurrent malignancy exceptions include: Curatively treated carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal- or squamous-cell skin cancer, Stage I melanoma, or low-grade, early-stage localized prostate cancer. Any previously treated early-stage non-hematological malignancy that has been in remission for at least 2 years is also permitted. * Patients with active gastrointestinal conditions (Crohn's disease, ulcerative colitis, diverticulosis associated colitis, and Behçet's disease) * Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade ≤1 (according to the NCI CTCAE, v4.0) prior to Cycle 1 Day 1 * Cardiovascular disease, such as: uncontrolled arterial hypertension; symptomatic congestive heart failure or ejection fraction below 55% at screening, or left ventricular hypertrophy; any significant structural abnormality of the heart at screening echocardiogram; unstable angina pectoris; presence or history of any type of supraventricular and ventricular arrhythmias, including lone atrial fibrillation or flutter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ruxolitinib-Naïve Participants With Splenomegaly at Baseline Who Achieved Composite Response at Week 32 | Week 32 | Composite response is defined as hematocrit (Hct) control without phlebotomy and ≥35% decrease in spleen size by imaging at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct of ≥45% that was ≥3% higher than baseline level or a Hct of \>48%. One Cycle is 28 Days. |
| Percentage of Ruxolitinib-Naïve Participants Without Splenomegaly at Baseline Who Achieved Hematocrit (Hct) Control Without Phlebotomy at Week 32 | Week 32 | Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%. |
| Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32 | Week 32 | Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%. |
| Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32 | From Baseline to Week 32 (Cycle 8 Day 28) | Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose) | Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study. |
| Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose) | Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study. |
| Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years) | The percentage of participants with a durable response lasting at least 12 weeks from Week 32 are analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study. |
| Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years) | The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years) | The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study. |
| Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years) | The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years) | The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study. |
| Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years) | The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Baseline to end of study (up to 2 years) | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. The adverse event severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity. During the final analyses, the focus was on the Adverse Events of severity grades \>/=3 as shown below. The extensive listings of all grade AEs are available at request. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters. | Baseline to end of study (up to 2 years) | Hematology parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low. There was no clinical laboratory abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. |
| Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters | Baseline to end of study (up to 2 years) | Clinical chemistry parameter laboratory values falling outside the standard reference range were to be recorded as either high or low. There was no clinical chemistry abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. |
| Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters | Baseline to end of study (up to 2 years) | Urinalysis parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low. There was no clinical laboratory (urinalysis) abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. |
| Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour) | Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour) | Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Change From Baseline in Oral Temperature | Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. |
| Change From Baseline in Pulse Rate | Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32 | Week 32 (Cycle 8 Day 28) | Complete hematologic response requires all of the following: Hct control without phlebotomy; White blood cell (WBC) count ≤10 × 10\^9/Liter (L) at Week 32; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%. |
| Change From Baseline in Systolic Blood Pressure | Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Change From Baseline in Diastolic Blood Pressure | Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline | The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all pre-disease activities without restriction), 1=Symptomatic but completely ambulatory, 2=Symptomatic, \< 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, \> 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Only baseline data were collectable. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the planned end of study. |
| Percentage of Participants With Concomitant Medications | Overall Study Period | Participants with Concomitant Medications used from 28 days prior to screening until the final visit or end of study (EOS) were reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Maximum Serum Concentration Observed (Cmax) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | Cmax is the maximum observed concentration of drug in blood. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Trough Concentration (Ctrough) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Time of Maximum Concentration Observed (Tmax) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | Tmax is the time elapsed from the time of drug administration to maximum plasma concentration. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Clearance (CL) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | CL is a measure of the body's elimination of a drug from plasma over time. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Apparent Clearance (CL/F) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | CL/F is a measure of the body's elimination of a drug from plasma over time, after oral administration. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Volume or Apparent Volume of Distribution (Vdss/F) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | Vdss/F is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the plasma. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Area Under the Concentration-Time Curve (AUC) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | AUC (from zero to infinity) represents the total drug exposure over time. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Half-life (t1/2) of Idasanutlin | Days 1, 2, and 5 of Cycles 1 and 4 | t1/2 is defined as the time required for the drug plasma concentration to be reduced to half. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study. |
| Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Days 28 of Cycles 3, 5, 8 (Week 32), 11, 14, 17 ) Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and Final Visit | MPN-SAF Total Symptom Score is the sum of the following 10 items: early satiety, abdominal discomfort, inactivity, concentration issues, night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months and fatigue. The participant provides a severity score for each symptom on a scale of 0 as a minimum score (none/absent) to 10 (worst imaginable) as a maximum score. Baseline (Cycle 1, Day 1) MPN-SAF total symptom score and the mean change from baseline score at each timepoint are reported. The change from baseline score was calculated by subtracting the post-baseline score from the baseline score. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study. |
| Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Cycles 3, 5, 8, 11, 14, 17, 20 Day 28 and Final Visit | Reported EORTC QLQ-C30 Scores include: Cognitive function, Diarrhea Emotional functioning, Nausea and vomiting, Social functioning, Physical functioning, Global health status/QoL and Role functioning. The questions use a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores are averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study. |
| Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2 Day 1, Cycle 3 Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and every 3 cycles thereafter (1 cycle is 28 days) until end of study (up to 2 years) | The PGIC is a one-item measure used to assess perceived treatment benefit. Participants were asked Since the start of the treatment you've received in this study, your polycythemia vera (PV) symptoms are: 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse'. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. |
| Change From Baseline in Respiratory Rate | Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study. |
| Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28 | Cycle 11 Day 28 | Complete hematologic remission requires all of the following: Hct control without phlebotomy between Weeks 32 and Cycle 11 Day 28; WBC count ≤10 × 10\^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%. |
| Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Week 32 (Cycle 8 Day 28), Cycle 11 Day 28 | Complete hematologic remission requires all of the following: Hct control without phlebotomy between Week 32 (Cycle 8 Day 28) and Cycle 11 Day 28; WBC count ≤10 × 10\^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48% |
| Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose) | Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study. |
Countries
Australia, Canada, Italy, United States
Participant flow
Recruitment details
A total of 48 participants were screened for enrollment; 21 were failed screening. 27 were enrolled and received study treatment. All 27 patients were discontinued from study before the planned date of follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitinib-naïve Participants With Splenomegaly Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years). | 15 |
| Ruxolitinib-naïve Participants Without Splenomegaly Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years). | 5 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years) | 6 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years) | 1 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 2 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 3 | 0 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Ruxolitinib-naïve Participants With Splenomegaly | Ruxolitinib-naïve Participants Without Splenomegaly | Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.5 Years STANDARD_DEVIATION 10.7 | 56.8 Years STANDARD_DEVIATION 8.8 | 60.3 Years STANDARD_DEVIATION 8.4 | 55 Years STANDARD_DEVIATION 0 | 56.3 Years STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 5 Participants | 6 Participants | 1 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 14 Participants | 5 Participants | 6 Participants | 1 Participants | 26 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 4 Participants | 0 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 0 Participants | 2 Participants | 1 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 5 | 0 / 6 | 0 / 1 |
| other Total, other adverse events | 15 / 15 | 5 / 5 | 6 / 6 | 1 / 1 |
| serious Total, serious adverse events | 2 / 15 | 1 / 5 | 0 / 6 | 0 / 1 |
Outcome results
Primary
Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%.
Time frame: Week 32
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32 | 44.4 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32 | 100 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32 | 54.5 Percentage of Participants |
Primary
Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%.
Time frame: From Baseline to Week 32 (Cycle 8 Day 28)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32 | 75.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32 | 0 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32 | 60 Percentage of Participants |
Primary
Percentage of Ruxolitinib-Naïve Participants Without Splenomegaly at Baseline Who Achieved Hematocrit (Hct) Control Without Phlebotomy at Week 32
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%.
Time frame: Week 32
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve Participants Without Splenomegaly at Baseline Who Achieved Hematocrit (Hct) Control Without Phlebotomy at Week 32 | 100 Percentage of Participants |
Primary
Percentage of Ruxolitinib-Naïve Participants With Splenomegaly at Baseline Who Achieved Composite Response at Week 32
Composite response is defined as hematocrit (Hct) control without phlebotomy and ≥35% decrease in spleen size by imaging at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct of ≥45% that was ≥3% higher than baseline level or a Hct of \>48%. One Cycle is 28 Days.
Time frame: Week 32
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve Participants With Splenomegaly at Baseline Who Achieved Composite Response at Week 32 | 44.4 Percentage of Participants |
Secondary
Apparent Clearance (CL/F) of Idasanutlin
CL/F is a measure of the body's elimination of a drug from plasma over time, after oral administration. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine CL/F as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Area Under the Concentration-Time Curve (AUC) of Idasanutlin
AUC (from zero to infinity) represents the total drug exposure over time. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine AUC as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time
Reported EORTC QLQ-C30 Scores include: Cognitive function, Diarrhea Emotional functioning, Nausea and vomiting, Social functioning, Physical functioning, Global health status/QoL and Role functioning. The questions use a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores are averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study.
Time frame: Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Cycles 3, 5, 8, 11, 14, 17, 20 Day 28 and Final Visit
Population: ITT Population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 14 Day 28 | 5.56 Score on a Scale | Standard Deviation 10.09 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 11 Day 28 | -2.78 Score on a Scale | Standard Deviation 19.48 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 14 Day 28 | 5.56 Score on a Scale | Standard Deviation 8.61 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 17 Day 28 | 8.33 Score on a Scale | Standard Deviation 9.62 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Final Visit | -13.33 Score on a Scale | Standard Deviation 32.24 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 2 Day 1 | 2.31 Score on a Scale | Standard Deviation 18.92 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 3 Day 28 | 7.89 Score on a Scale | Standard Deviation 14.56 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 11 Day 28 | 1.39 Score on a Scale | Standard Deviation 23.81 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 14 Day 28 | 2.78 Score on a Scale | Standard Deviation 21.52 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 20 Day 28 | 25.00 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Baseline | 65.83 Score on a Scale | Standard Deviation 32.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 5 Day 28 | 1.19 Score on a Scale | Standard Deviation 22.13 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 8 (Week 32) | 6.06 Score on a Scale | Standard Deviation 18.67 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 11 Day 28 | 8.33 Score on a Scale | Standard Deviation 13.94 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 14 Day 28 | 5.56 Score on a Scale | Standard Deviation 17.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 17 Day 28 | 0.00 Score on a Scale | Standard Deviation 13.61 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Baseline | 8.33 Score on a Scale | Standard Deviation 18.34 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 14 Day 28 | 5.56 Score on a Scale | Standard Deviation 13.61 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 17 Day 28 | 25.00 Score on a Scale | Standard Deviation 31.91 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Baseline | 65.83 Score on a Scale | Standard Deviation 28.34 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 5 Day 28 | -2.38 Score on a Scale | Standard Deviation 11.05 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 5 Day 28 | 5.95 Score on a Scale | Standard Deviation 24.98 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Final visit | 0.00 Score on a Scale | Standard Deviation 30.86 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 2 Day 1 | 1.48 Score on a Scale | Standard Deviation 9.02 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 3 Day 28 | -2.81 Score on a Scale | Standard Deviation 15.45 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 5 Day 28 | 1.43 Score on a Scale | Standard Deviation 16.16 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 8 (Week 32) | 5.45 Score on a Scale | Standard Deviation 15.72 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 11 Day 28 | -1.11 Score on a Scale | Standard Deviation 6.55 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 14 Day 28 | -1.11 Score on a Scale | Standard Deviation 2.72 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 17 Day 28 | 1.67 Score on a Scale | Standard Deviation 3.33 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Final visit | -4.44 Score on a Scale | Standard Deviation 9.65 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Baseline | 61.25 Score on a Scale | Standard Deviation 20.28 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 5 Day 28 | 7.14 Score on a Scale | Standard Deviation 19.84 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 8 (Week 32) | 9.09 Score on a Scale | Standard Deviation 23.41 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 17 Day 28 | 10.42 Score on a Scale | Standard Deviation 20.83 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Final visit | -3.33 Score on a Scale | Standard Deviation 23.32 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Baseline | 74.17 Score on a Scale | Standard Deviation 28.85 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 2 Day 1 | 7.41 Score on a Scale | Standard Deviation 17.36 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 3 Day 28 | 2.63 Score on a Scale | Standard Deviation 17.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 5 Day 28 | 7.14 Score on a Scale | Standard Deviation 15.63 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 8 (Week 32) | 15.15 Score on a Scale | Standard Deviation 21.67 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 20 Day 28 | 16.67 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 2, Day 1 | 11.11 Score on a Scale | Standard Deviation 11.43 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 3 Day 28 | 7.02 Score on a Scale | Standard Deviation 16.02 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Final Visit | 4.44 Score on a Scale | Standard Deviation 18.33 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 2 Day 1 | -5.56 Score on a Scale | Standard Deviation 17.15 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 3 Day 28 | 1.75 Score on a Scale | Standard Deviation 17.48 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 5 Day 28 | 7.14 Score on a Scale | Standard Deviation 19.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 8 (Week 32) | 9.09 Score on a Scale | Standard Deviation 26.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 11 Day 28 | 5.56 Score on a Scale | Standard Deviation 13.61 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Final visit | 13.33 Score on a Scale | Standard Deviation 32.85 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 1 Day 28 | 13.43 Score on a Scale | Standard Deviation 20.24 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 3 Day 28 | 14.04 Score on a Scale | Standard Deviation 21.88 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 5 Day 28 | 16.07 Score on a Scale | Standard Deviation 20.53 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 8 (Week 32) | 14.39 Score on a Scale | Standard Deviation 18.29 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 11 Day 28 | 6.94 Score on a Scale | Standard Deviation 11.08 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 17 Day 28 | -8.33 Score on a Scale | Standard Deviation 16.67 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Final visit | 3.33 Score on a Scale | Standard Deviation 18.31 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Baseline | 10.00 Score on a Scale | Standard Deviation 16.58 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 2 Day 1 | -4.63 Score on a Scale | Standard Deviation 12.53 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 3 Day 28 | -1.75 Score on a Scale | Standard Deviation 17.48 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 8 (Week 32) | 7.58 Score on a Scale | Standard Deviation 23.99 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 11 Day 28 | 2.78 Score on a Scale | Standard Deviation 12.55 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 14 Day 28 | -2.78 Score on a Scale | Standard Deviation 6.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Final visit | 11.11 Score on a Scale | Standard Deviation 33.73 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Baseline | 67.50 Score on a Scale | Standard Deviation 35.24 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 2 Day 1 | 4.63 Score on a Scale | Standard Deviation 12.53 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 3 Day 28 | -1.75 Score on a Scale | Standard Deviation 22.15 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 8 (Week 32) | 0.00 Score on a Scale | Standard Deviation 18.26 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 11 Day 28 | 0.00 Score on a Scale | Standard Deviation 18.26 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 14 Day 28 | 0.00 Score on a Scale | Standard Deviation 10.54 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 17 Day 28 | -4.17 Score on a Scale | Standard Deviation 8.33 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Baseline | 86.33 Score on a Scale | Standard Deviation 18.92 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Final visit | 6.67 Score on a Scale | Standard Deviation 19 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 8 (Week 32) | 0.00 Score on a Scale | Standard Deviation 20.41 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 20 Day 28 | 8.33 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 11 Day 28 | -8.33 Score on a Scale | Standard Deviation 11.79 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 14 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 17 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 11 Day 28 | -10.00 Score on a Scale | Standard Deviation 14.14 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 17 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Final visit | -2.67 Score on a Scale | Standard Deviation 7.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Baseline | 60.71 Score on a Scale | Standard Deviation 7.93 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Final Visit | 6.67 Score on a Scale | Standard Deviation 9.13 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 2 Day 1 | 1.39 Score on a Scale | Standard Deviation 8.19 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Final visit | 16.67 Score on a Scale | Standard Deviation 18.63 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 2, Day 1 | 8.33 Score on a Scale | Standard Deviation 13.94 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Baseline | 76.19 Score on a Scale | Standard Deviation 13.11 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 14 Day 28 | 8.33 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 3 Day 28 | 6.67 Score on a Scale | Standard Deviation 19 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 8 (Week 32) | -3.33 Score on a Scale | Standard Deviation 21.73 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Baseline | 76.19 Score on a Scale | Standard Deviation 30.21 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Baseline | 2.38 Score on a Scale | Standard Deviation 6.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 5 Day 28 | 11.11 Score on a Scale | Standard Deviation 25.09 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Final Visit | 6.67 Score on a Scale | Standard Deviation 9.13 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 14 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 11 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 2 Day 1 | 5.56 Score on a Scale | Standard Deviation 13.61 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 14 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 2 Day 1 | 8.33 Score on a Scale | Standard Deviation 22.97 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 17 Day 28 | -8.33 Score on a Scale | Standard Deviation 11.79 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 3 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Cognitive function Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Final visit | -6.67 Score on a Scale | Standard Deviation 25.28 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Baseline | 14.29 Score on a Scale | Standard Deviation 17.82 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 5 Day 28 | 5.56 Score on a Scale | Standard Deviation 13.61 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 14 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 3 Day 28 | 3.33 Score on a Scale | Standard Deviation 13.94 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 8 (Week 32) | 20.00 Score on a Scale | Standard Deviation 18.26 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 5 Day 28 | -2.78 Score on a Scale | Standard Deviation 22.15 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 14 Day 28 | -4.17 Score on a Scale | Standard Deviation 5.89 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 5 Day 28 | 8.33 Score on a Scale | Standard Deviation 17.48 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 14 Day 28 | -8.33 Score on a Scale | Standard Deviation 11.79 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 2 Day 1 | 0.00 Score on a Scale | Standard Deviation 10.54 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 3 Day 28 | 3.33 Score on a Scale | Standard Deviation 13.94 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 11 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 17 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 5 Day 28 | -2.78 Score on a Scale | Standard Deviation 26.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 2 Day 1 | 2.22 Score on a Scale | Standard Deviation 6.89 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 3 Day 28 | 2.67 Score on a Scale | Standard Deviation 5.96 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 8 (Week 32) | 16.67 Score on a Scale | Standard Deviation 16.67 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 5 Day 28 | -2.22 Score on a Scale | Standard Deviation 5.44 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Diarrhea Final visit | 6.67 Score on a Scale | Standard Deviation 14.91 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 8 (Week 32) | -4.00 Score on a Scale | Standard Deviation 7.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Baseline | 64.29 Score on a Scale | Standard Deviation 21.36 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 17 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 14 Day 28 | 0.00 Score on a Scale | Standard Deviation 9.43 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 1 Day 28 | 15.28 Score on a Scale | Standard Deviation 13.35 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 11 Day 28 | 0.00 Score on a Scale | Standard Deviation 23.57 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 3 Day 28 | 8.33 Score on a Scale | Standard Deviation 10.21 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 8 (Week 32) | -6.67 Score on a Scale | Standard Deviation 19 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 3 Day 28 | 11.67 Score on a Scale | Standard Deviation 9.5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 5 Day 28 | 6.94 Score on a Scale | Standard Deviation 16.17 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 5 Day 28 | 0.00 Score on a Scale | Standard Deviation 17.48 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Physical functioning Baseline | 81.90 Score on a Scale | Standard Deviation 11.36 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 8 (Week 32) | -8.33 Score on a Scale | Standard Deviation 13.18 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 11 Day 28 | 8.33 Score on a Scale | Standard Deviation 11.79 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 8 (Week 32) | 5.00 Score on a Scale | Standard Deviation 27.39 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 17 Day 28 | 16.67 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 20 Day 28 | 25.00 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 20 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Global health status/QoL Final visit | 13.33 Score on a Scale | Standard Deviation 17.28 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 11 Day 28 | 16.67 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Baseline | 76.19 Score on a Scale | Standard Deviation 16.27 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Social functioning Cycle 11 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 2 Day 1 | -8.33 Score on a Scale | Standard Deviation 17.48 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Emotional functioning Cycle 17 Day 28 | 0 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores Over Time | EORTC QLQ-C30 Scores: Role functioning Cycle 3 Day 28 | 0.00 Score on a Scale | Standard Deviation 11.79 |
Secondary
Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time
MPN-SAF Total Symptom Score is the sum of the following 10 items: early satiety, abdominal discomfort, inactivity, concentration issues, night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months and fatigue. The participant provides a severity score for each symptom on a scale of 0 as a minimum score (none/absent) to 10 (worst imaginable) as a maximum score. Baseline (Cycle 1, Day 1) MPN-SAF total symptom score and the mean change from baseline score at each timepoint are reported. The change from baseline score was calculated by subtracting the post-baseline score from the baseline score. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study.
Time frame: Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Days 28 of Cycles 3, 5, 8 (Week 32), 11, 14, 17 ) Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and Final Visit
Population: ITT Population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Final Visit | -5.92 Score on a Scale | Standard Deviation 9.96 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 5 Day 28, | -7.00 Score on a Scale | Standard Deviation 12.72 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 11 Day 28 | -4.60 Score on a Scale | Standard Deviation 3.71 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 20 Day 28 | -12.00 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Baseline (Cycle 1 Day 1) | 31.95 Score on a Scale | Standard Deviation 19.95 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 3 Day 28 | -6.38 Score on a Scale | Standard Deviation 12.71 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Week 32 | -8.20 Score on a Scale | Standard Deviation 12.79 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 14 Day 28 | -4.67 Score on a Scale | Standard Deviation 5.54 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 17 Day 28 | -3.25 Score on a Scale | Standard Deviation 5.38 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 2 Day 1 | -5.06 Score on a Scale | Standard Deviation 12.91 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 3 Day 28 | -8.00 Score on a Scale | Standard Deviation 15.08 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Baseline (Cycle 1 Day 1) | 26.00 Score on a Scale | Standard Deviation 11.83 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 5 Day 28, | -9.50 Score on a Scale | Standard Deviation 10.56 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Week 32 | -5.00 Score on a Scale | Standard Deviation 15.26 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 2 Day 1 | 0.80 Score on a Scale | Standard Deviation 26.37 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 11 Day 28 | -7.50 Score on a Scale | Standard Deviation 3.54 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 17 Day 28 | -12.00 Score on a Scale | Standard Deviation 1.41 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 14 Day 28 | -10.50 Score on a Scale | Standard Deviation 4.95 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Cycle 20 Day 28 | -8.00 Score on a Scale | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Baseline and Mean Change From Baseline Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Over Time | Final Visit | -7.20 Score on a Scale | Standard Deviation 5.63 |
Secondary
Change From Baseline in Diastolic Blood Pressure
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 22, Day 1 | 22.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3, Day 15 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 12, Day 1 | 9.8 Millimeters of mercury (mmHg) | Standard Deviation 8.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 16, Day 1 | 9.8 Millimeters of mercury (mmHg) | Standard Deviation 7.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 21, Day 1 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 4, Day 1 | 5.5 Millimeters of mercury (mmHg) | Standard Deviation 5.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 15, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Baseline | 76.3 Millimeters of mercury (mmHg) | Standard Deviation 7.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 20, Day 1 | 12.5 Millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 5, Day 1 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 11, Day 1 | 9.7 Millimeters of mercury (mmHg) | Standard Deviation 14.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 6, Day 1 | 5.9 Millimeters of mercury (mmHg) | Standard Deviation 4.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 13, Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 19, Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 5.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 8, Day 1 | 7.8 Millimeters of mercury (mmHg) | Standard Deviation 5.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 17, Day 1 | 11.3 Millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 1, Day 22 | 3.6 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 18, Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 1.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 9, Day 1 | 4.1 Millimeters of mercury (mmHg) | Standard Deviation 8.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle1, Day 15 | 5.1 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 7, Day 1 | 2.9 Millimeters of mercury (mmHg) | Standard Deviation 4.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 10, Day 1 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 5.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 15 | 4.1 Millimeters of mercury (mmHg) | Standard Deviation 6.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Final visit | 5.8 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3 Day 1 | 6.2 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 14, Day 1 | 5.6 Millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 1 | 6.1 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 17, Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 10, Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 7, Day 1 | 4.5 Millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 11, Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 16, Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 13, Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 14, Day 1 | 19.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle1, Day 15 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 15, Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Baseline | 73.2 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Final visit | 3.8 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 1, Day 22 | 2.4 Millimeters of mercury (mmHg) | Standard Deviation 3.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3 Day 1 | 5.8 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 15 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3, Day 15 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 2.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 4, Day 1 | 2.7 Millimeters of mercury (mmHg) | Standard Deviation 6.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 5, Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 5.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 6, Day 1 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 11.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 8, Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 12, Day 1 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 9, Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 5.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Baseline | 72.3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 1 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 9.3 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 15 | -5.5 Millimeters of mercury (mmHg) | Standard Deviation 3.4 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 7, Day 1 | -5.3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle1, Day 15 | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 3.4 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 1, Day 22 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 5.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 3 Day 1 | -4.0 Millimeters of mercury (mmHg) | Standard Deviation 12.4 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 3, Day 15 | -7.5 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 4, Day 1 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 5, Day 1 | -5.0 Millimeters of mercury (mmHg) | Standard Deviation 4.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 6, Day 1 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 9.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 8, Day 1 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 12.3 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 9, Day 1 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 1.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 10, Day 1 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 11, Day 1 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 12, Day 1 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 13, Day 1 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 14, Day 1 | -9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 16, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 17, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 18, Day 1 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 19, Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 20, Day 1 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Final visit | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 12.6 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Diastolic Blood Pressure | Cycle 15, Day 1 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 8, Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 16, Day 1 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 18, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 7, Day 1 | 30.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 21, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 19, Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 4, Day 1 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 5, Day 1 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 20, Day 1 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3, Day 15 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 3 Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 22, Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 23, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 15 | 16.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle1, Day 15 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 2, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Final visit | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 11, Day 1 | 24.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Baseline | 65.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 6, Day 1 | 12.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 13, Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 14, Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 12, Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 1, Day 22 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 10, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 9, Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 15, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Diastolic Blood Pressure | Cycle 17, Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
Secondary
Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations
Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
Population: Safety-Evaluable population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | 1.00 Millisecond (msec) | Standard Deviation 8.78 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 2 Day 1 (PREDOSE) | 5.00 Millisecond (msec) | Standard Deviation 22.68 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | -1.27 Millisecond (msec) | Standard Deviation 11.86 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 4 Day 1, 4 H | -62.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Durations Cycle 3 Day 1 (PREDOSE) | -2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Durations Cycle 3 Day 1 (4 H) | -10.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Durations Cycle 3 Day 1 (6 H) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Durations Cycle 4 Day 1 (PREDOSE) | -16.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Durations Cycle 4 Day 1 (4 H) | -16.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB baseline | 427.67 Millisecond (msec) | Standard Deviation 24.23 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (6 H) | -21.46 Millisecond (msec) | Standard Deviation 121.82 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 4 Day 1 (PREDOSE) | -62.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (6 H) | 8.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | 3.80 Millisecond (msec) | Standard Deviation 12.82 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | 8.00 Millisecond (msec) | Standard Deviation 10.54 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Baseline | 417.93 Millisecond (msec) | Standard Deviation 22.41 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (PREDOSE) | -16.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | 3.93 Millisecond (msec) | Standard Deviation 14.42 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (PREDOSE) | -15.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 2, Day1, pre-dose | 1.43 Millisecond (msec) | Standard Deviation 14.26 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | 3.71 Millisecond (msec) | Standard Deviation 15.59 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 3 Day 1 (4 H) | -59.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | -4.54 Millisecond (msec) | Standard Deviation 16.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | -2.92 Millisecond (msec) | Standard Deviation 14.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | -11.07 Millisecond (msec) | Standard Deviation 15.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (4 H) | 6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 4 Day 1 (4 H) | -62.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (PREDOSE) | -6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 3, Day 1, pre-dose | -6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 3, Day 1, 4 hour | -8.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 3, Day 1, 6 hour | -6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 4, Day 1, pre-dose | -20.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 4, Day 1, 4 hour | -20.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Duration Baseline | 90.87 Millisecond (msec) | Standard Deviation 8.25 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 3 Day 1 (PREDOSE) | 48.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 3 Day 1 (4 H) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 3 Day 1 (PREDOSE) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (4 H) | -1.47 Millisecond (msec) | Standard Deviation 5.83 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, pre-dose | -14.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PR Duration Baseline | 158.93 Millisecond (msec) | Standard Deviation 24.86 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (6 H) | -1.27 Millisecond (msec) | Standard Deviation 5.27 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 4 hour | 0.60 Millisecond (msec) | Standard Deviation 10.89 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, 24 hour | 1.93 Millisecond (msec) | Standard Deviation 10.32 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 6 hour | -2.80 Millisecond (msec) | Standard Deviation 8.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (PREDOSE) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (24 H) | 1.07 Millisecond (msec) | Standard Deviation 3.77 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 4 Day 1 (4 H) | 182.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 6 H | -65.67 Millisecond (msec) | Standard Deviation 117.44 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 4 H | -38.87 Millisecond (msec) | Standard Deviation 130.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (PREDOSE) | 0.13 Millisecond (msec) | Standard Deviation 4.63 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 2 Day 1 (PREDOSE) | 7.14 Millisecond (msec) | Standard Deviation 118.26 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Baseline | 861.47 Millisecond (msec) | Standard Deviation 133.95 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 4 Day 1 (4 H) | -45.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (4 H) | -1.08 Millisecond (msec) | Standard Deviation 3.12 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (4 H) | -26.23 Millisecond (msec) | Standard Deviation 114 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 4 Day 1 (PREDOSE) | -45.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (6 H) | -0.92 Millisecond (msec) | Standard Deviation 4.73 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (6 H) | 4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (4 H) | 0.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 2 Day 1 (PREDOSE) | 0.64 Millisecond (msec) | Standard Deviation 6.25 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | -1.00 Millisecond (msec) | Standard Deviation 11.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (PREDOSE) | -11.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 3 Day 1 (6 H) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 4 Day 1 (PREDOSE) | -2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 4 Day 1 (4 H) | -2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Baseline | 396.67 Millisecond (msec) | Standard Deviation 31.96 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (4 H) | -7.33 Millisecond (msec) | Standard Deviation 26.43 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 4 Day 1 (PREDOSE) | 182.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | 3.36 Millisecond (msec) | Standard Deviation 10.49 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | -7.85 Millisecond (msec) | Standard Deviation 13.44 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (6 H) | -9.40 Millisecond (msec) | Standard Deviation 23.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (PREDOSE) | 25.87 Millisecond (msec) | Standard Deviation 97.32 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | -0.08 Millisecond (msec) | Standard Deviation 26.39 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 4 hour | -8.00 Millisecond (msec) | Standard Deviation 12.68 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (24 H) | -10.21 Millisecond (msec) | Standard Deviation 25.57 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 3 Day 1 (6 H) | -43.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | -10.47 Millisecond (msec) | Standard Deviation 14.17 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (PREDOSE) | -6.20 Millisecond (msec) | Standard Deviation 19.79 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (24 H) | -51.50 Millisecond (msec) | Standard Deviation 121.75 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (4 H) | -4.31 Millisecond (msec) | Standard Deviation 33.31 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (PREDOSE) | 28.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | -2.36 Millisecond (msec) | Standard Deviation 13.32 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (6 H) | -10.31 Millisecond (msec) | Standard Deviation 24.83 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 6 hour | -4.77 Millisecond (msec) | Standard Deviation 14.08 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (PREDOSE) | -12.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (6 H) | -0.25 Millisecond (msec) | Standard Deviation 5.19 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PR Duration Baseline | 153.60 Millisecond (msec) | Standard Deviation 22.55 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 4 hour | -2.60 Millisecond (msec) | Standard Deviation 5.37 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, pre-dose | -6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, 24 hour | 1.00 Millisecond (msec) | Standard Deviation 16.45 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | -12.00 Millisecond (msec) | Standard Deviation 9.38 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 4 hour | -6.25 Millisecond (msec) | Standard Deviation 15.59 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 2, Day1, pre-dose | -5.75 Millisecond (msec) | Standard Deviation 11.79 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Duration Baseline | 83.80 Millisecond (msec) | Standard Deviation 6.42 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (4 H) | 4.60 Millisecond (msec) | Standard Deviation 6.69 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (6 H) | 4.00 Millisecond (msec) | Standard Deviation 3.08 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (24 H) | 1.75 Millisecond (msec) | Standard Deviation 6.55 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (PREDOSE) | 4.00 Millisecond (msec) | Standard Deviation 9.09 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (4 H) | 3.75 Millisecond (msec) | Standard Deviation 9.46 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 2 Day 1 (PREDOSE) | 7.75 Millisecond (msec) | Standard Deviation 9.46 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (4 H) | 16.80 Millisecond (msec) | Standard Deviation 13.44 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (6 H) | 11.00 Millisecond (msec) | Standard Deviation 29.14 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (PREDOSE) | -18.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (24 H) | 2.75 Millisecond (msec) | Standard Deviation 29 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (PREDOSE) | -8.75 Millisecond (msec) | Standard Deviation 21 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (4 H) | 15.25 Millisecond (msec) | Standard Deviation 15.65 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (6 H) | 4.75 Millisecond (msec) | Standard Deviation 20.93 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB baseline | 419.60 Millisecond (msec) | Standard Deviation 7.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | 8.40 Millisecond (msec) | Standard Deviation 22.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (PREDOSE) | -410.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | -0.75 Millisecond (msec) | Standard Deviation 16.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | -10.00 Millisecond (msec) | Standard Deviation 8.76 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | 1.50 Millisecond (msec) | Standard Deviation 8.81 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | -4.75 Millisecond (msec) | Standard Deviation 6.18 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | 18.80 Millisecond (msec) | Standard Deviation 10.08 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | 10.00 Millisecond (msec) | Standard Deviation 21.64 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (PREDOSE) | -20.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | 0.00 Millisecond (msec) | Standard Deviation 20.46 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | -9.25 Millisecond (msec) | Standard Deviation 8.96 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | 4.00 Millisecond (msec) | Standard Deviation 8.98 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | -2.25 Millisecond (msec) | Standard Deviation 8.46 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | 8 Millisecond (msec) | Standard Deviation 20.51 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Baseline | 881.00 Millisecond (msec) | Standard Deviation 151.46 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 6 hour | -4.40 Millisecond (msec) | Standard Deviation 15.52 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 6 hour | -2.75 Millisecond (msec) | Standard Deviation 10.81 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (PREDOSE) | 2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Baseline | 392.60 Millisecond (msec) | Standard Deviation 38.74 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 2 Day 1 (PREDOSE) | 10.50 Millisecond (msec) | Standard Deviation 25.96 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | 21.00 Millisecond (msec) | Standard Deviation 11.14 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | 7.75 Millisecond (msec) | Standard Deviation 20.61 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Baseline | 410.00 Millisecond (msec) | Standard Deviation 17.62 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 4 H | -5.60 Millisecond (msec) | Standard Deviation 58.23 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 6 H | 14.00 Millisecond (msec) | Standard Deviation 100.82 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (PREDOSE) | 18.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (24 H) | 17.25 Millisecond (msec) | Standard Deviation 65.17 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (PREDOSE) | -0.75 Millisecond (msec) | Standard Deviation 104.53 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (4 H) | 79.75 Millisecond (msec) | Standard Deviation 62.99 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (6 H) | 49.50 Millisecond (msec) | Standard Deviation 99.21 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 2 Day 1 (PREDOSE) | 23.75 Millisecond (msec) | Standard Deviation 86.53 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | -3.20 Millisecond (msec) | Standard Deviation 14.6 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (4 H) | 3.20 Millisecond (msec) | Standard Deviation 24.23 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 4 hour | -2.00 Millisecond (msec) | Standard Deviation 9.72 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (6 H) | 33.00 Millisecond (msec) | Standard Deviation 59.05 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | 13.83 Millisecond (msec) | Standard Deviation 14.05 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | 0.40 Millisecond (msec) | Standard Deviation 26.59 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 2, Day1, pre-dose | -2.33 Millisecond (msec) | Standard Deviation 11.89 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (24 H) | 3.00 Millisecond (msec) | Standard Deviation 11.64 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | 0.17 Millisecond (msec) | Standard Deviation 14.54 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PR Duration Baseline | 152.00 Millisecond (msec) | Standard Deviation 17.39 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | 5.33 Millisecond (msec) | Standard Deviation 14.81 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, 24 hour | 0.67 Millisecond (msec) | Standard Deviation 22.01 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (4 H) | 5.67 Millisecond (msec) | Standard Deviation 10.07 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | -2.00 Millisecond (msec) | Standard Deviation 17.36 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | 1.60 Millisecond (msec) | Standard Deviation 14.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (6 H) | 0.33 Millisecond (msec) | Standard Deviation 5.28 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 4 H | -36.50 Millisecond (msec) | Standard Deviation 66.76 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 6 hour | 6.00 Millisecond (msec) | Standard Deviation 25.49 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | 6.83 Millisecond (msec) | Standard Deviation 12.45 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 6 hour | 7.60 Millisecond (msec) | Standard Deviation 27.29 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 2 Day 1 (PREDOSE) | 78.17 Millisecond (msec) | Standard Deviation 59.85 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (6 H) | -1.33 Millisecond (msec) | Standard Deviation 13.49 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | -9.20 Millisecond (msec) | Standard Deviation 15.25 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (4 H) | 24.20 Millisecond (msec) | Standard Deviation 114.05 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 6 H | -31.17 Millisecond (msec) | Standard Deviation 49.04 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | -4.60 Millisecond (msec) | Standard Deviation 18.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 2 Day 1 (PREDOSE) | 1.00 Millisecond (msec) | Standard Deviation 2.76 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | 4.50 Millisecond (msec) | Standard Deviation 14.47 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (4 H) | 1.33 Millisecond (msec) | Standard Deviation 1.03 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | -1.60 Millisecond (msec) | Standard Deviation 15.44 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (24 H) | 7.00 Millisecond (msec) | Standard Deviation 16.58 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (6 H) | 2.00 Millisecond (msec) | Standard Deviation 5.83 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | 6.33 Millisecond (msec) | Standard Deviation 5.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Duration Baseline | 83.33 Millisecond (msec) | Standard Deviation 9.77 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB baseline | 424.50 Millisecond (msec) | Standard Deviation 25.74 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (4 H) | -0.40 Millisecond (msec) | Standard Deviation 2.61 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Baseline | 411.17 Millisecond (msec) | Standard Deviation 17.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 2 Day 1 (PREDOSE) | 19.00 Millisecond (msec) | Standard Deviation 13.67 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Baseline | 386.00 Millisecond (msec) | Standard Deviation 16.78 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | 11.67 Millisecond (msec) | Standard Deviation 11.09 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (24 H) | 8.83 Millisecond (msec) | Standard Deviation 29.78 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (PREDOSE) | 0.00 Millisecond (msec) | Standard Deviation 2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (PREDOSE) | 67.80 Millisecond (msec) | Standard Deviation 78.89 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | 3.50 Millisecond (msec) | Standard Deviation 7.37 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Baseline | 835.83 Millisecond (msec) | Standard Deviation 139.93 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (6 H) | 7.60 Millisecond (msec) | Standard Deviation 16.4 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 4 hour | -1.20 Millisecond (msec) | Standard Deviation 29.52 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (PREDOSE) | 8.00 Millisecond (msec) | Standard Deviation 19.54 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (4 H) | -12.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | -9.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | -3.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 2 (24 H) | 54.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (4 H) | 36.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | 6.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | -11.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (6 H) | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (PREDOSE) | 2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Baseline | 779.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 2 (24 H) | -2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (6 H) | -2.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 2, 24 hour | -12.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 4 hour | 4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 1 (4 H) | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 1 Day 5 (4 H) | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Cycle 2 Day 1 (PREDOSE) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QRS Duration Baseline | 94.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (4 H) | -47.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Baseline | 392.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 1 (6 H) | 36.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 2, Day1, pre-dose | -8.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 2 (24 H) | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (PREDOSE) | 4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | -30.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (6 H) | -56.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | -23.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 6 hour | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Baseline | 426.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PR Duration Baseline | 196.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 4 H | 292.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 5 (PREDOSE) | 43.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | -7.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | -14.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | 0.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 1 Day 1 6 H | 130.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | -12.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | 5.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcB baseline | 444.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 2 Day 1 (PREDOSE) | 12.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 5, 4 hour | 0 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | -8.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QT Duration Cycle 1 Day 5 (6 H) | -4.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | RR Duration Cycle 2 Day 1 (PREDOSE) | 144.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | 16.00 Millisecond (msec) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Electrocardiogram Parameters: PQ(PR), QRS, QT, QTcB, QTcF, and RR Durations | PQ(PR) Durations Cycle 1, Day 1, 6 hour | 0.00 Millisecond (msec) | Standard Deviation 0 |
Secondary
Change From Baseline in Heart Rate, as Measured by Electrocardiogram
Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 3 Day 1, 6 hour | 5.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 6 hour | 2.23 Beats per Minute | Standard Deviation 9.39 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, pre-dose | -3.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 3 Day 1, 4 hour | 7.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 3 Day 1, pre-dose | -5.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 2, Day 1, pre-dose | -1.43 Beats per Minute | Standard Deviation 9.83 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 4 Hour | 4.40 Beats per Minute | Standard Deviation 10.58 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, pre-dose | -1.47 Beats per Minute | Standard Deviation 6.56 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 6 Hour | 6.20 Beats per Minute | Standard Deviation 10.35 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Baseline | 71.47 Beats per Minute | Standard Deviation 12.74 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 4 Day 1, 4 hour | -16.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 4 hour | 2.69 Beats per Minute | Standard Deviation 8.61 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, 24 Hour | 4.71 Beats per Minute | Standard Deviation 10.31 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 4 Day 1, pre-dose | -16.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 6 Hour | -0.60 Beats per Minute | Standard Deviation 8.65 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, pre-dose | -1.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, 24 Hour | -1.75 Beats per Minute | Standard Deviation 5.32 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, pre-dose | -0.75 Beats per Minute | Standard Deviation 8.14 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 4 hour | -5.00 Beats per Minute | Standard Deviation 2.94 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 6 hour | -3.75 Beats per Minute | Standard Deviation 7.76 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 2, Day 1, pre-dose | -1.50 Beats per Minute | Standard Deviation 8.39 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Baseline | 69.80 Beats per Minute | Standard Deviation 12.28 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 4 Hour | 0.60 Beats per Minute | Standard Deviation 5.32 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 6 hour | -2.80 Beats per Minute | Standard Deviation 4.92 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Baseline | 73.17 Beats per Minute | Standard Deviation 10.07 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 4 hour | -2.20 Beats per Minute | Standard Deviation 7.92 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 6 Hour | 3.00 Beats per Minute | Standard Deviation 5.44 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 4 Hour | 2.50 Beats per Minute | Standard Deviation 4.23 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, 24 Hour | -0.67 Beats per Minute | Standard Deviation 2.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 2, Day 1, pre-dose | -6.17 Beats per Minute | Standard Deviation 5.19 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, pre-dose | -5.60 Beats per Minute | Standard Deviation 5.27 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 2, Day 1, pre-dose | -12.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 4 hour | 5.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, pre-dose | -4.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Baseline | 77.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 6 Hour | -11.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 2, 24 Hour | -5.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1, Day 1, 4 Hour | -21.00 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Heart Rate, as Measured by Electrocardiogram | Cycle 1 Day 5, 6 hour | 6.00 Beats per Minute | Standard Deviation 0 |
Secondary
Change From Baseline in Oral Temperature
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study.
Time frame: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Baseline | 36.50 Degrees Celsius (C) | Standard Deviation 0.37 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 15 | 0.13 Degrees Celsius (C) | Standard Deviation 0.33 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 22 | 0.03 Degrees Celsius (C) | Standard Deviation 0.18 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 1 | -0.05 Degrees Celsius (C) | Standard Deviation 0.28 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 15 | 0.04 Degrees Celsius (C) | Standard Deviation 0.27 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 1 | -0.09 Degrees Celsius (C) | Standard Deviation 0.36 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 15 | -0.04 Degrees Celsius (C) | Standard Deviation 0.31 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 5 Day 1 | 0.05 Degrees Celsius (C) | Standard Deviation 0.16 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 7 Day 1 | 0.01 Degrees Celsius (C) | Standard Deviation 0.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 8 Day 1 | -0.01 Degrees Celsius (C) | Standard Deviation 0.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 9 Day 1 | 0.03 Degrees Celsius (C) | Standard Deviation 0.13 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 10 Day 1 | -0.08 Degrees Celsius (C) | Standard Deviation 0.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 11 Day 1 | -0.07 Degrees Celsius (C) | Standard Deviation 0.19 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 12 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0.16 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 15 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0.14 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 16 Day 1 | 0.03 Degrees Celsius (C) | Standard Deviation 0.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 17 Day 1 | 0.03 Degrees Celsius (C) | Standard Deviation 0.12 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 18 Day 1 | 0.07 Degrees Celsius (C) | Standard Deviation 0.15 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 19 Day 1 | -0.15 Degrees Celsius (C) | Standard Deviation 0.21 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 20 Day 1 | 0.00 Degrees Celsius (C) | Standard Deviation 0.14 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 21 Day 1 | 0 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 22 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Final Visit | -0.08 Degrees Celsius (C) | Standard Deviation 0.15 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 4 Day 1 | -0.05 Degrees Celsius (C) | Standard Deviation 0.26 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 6 Day 1 | -0.03 Degrees Celsius (C) | Standard Deviation 0.16 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 13 Day 1 | 0.00 Degrees Celsius (C) | Standard Deviation 0.19 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Oral Temperature | Cycle 14 Day 1 | 0.00 Degrees Celsius (C) | Standard Deviation 0.41 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 7 Day 1 | -0.20 Degrees Celsius (C) | Standard Deviation 0.28 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 4 Day 1 | -0.17 Degrees Celsius (C) | Standard Deviation 0.15 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 1 | 0.05 Degrees Celsius (C) | Standard Deviation 0.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 12 Day 1 | 0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 11 Day 1 | -0.20 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 8 Day 1 | -0.05 Degrees Celsius (C) | Standard Deviation 0.64 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 15 | 0.18 Degrees Celsius (C) | Standard Deviation 0.24 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 14 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 10 Day 1 | 0.30 Degrees Celsius (C) | Standard Deviation 0.42 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 22 | 0.04 Degrees Celsius (C) | Standard Deviation 0.29 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Final Visit | 0.26 Degrees Celsius (C) | Standard Deviation 0.26 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 15 Day 1 | -0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 6 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0.45 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 5 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0.36 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 1 | 0.13 Degrees Celsius (C) | Standard Deviation 0.45 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 16 Day 1 | -0.80 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 15 | 0.42 Degrees Celsius (C) | Standard Deviation 0.5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 9 Day 1 | 0.05 Degrees Celsius (C) | Standard Deviation 0.35 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 13 Day 1 | -0.70 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 17 Day 1 | 0.60 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Baseline | 36.40 Degrees Celsius (C) | Standard Deviation 0.25 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 15 | -0.03 Degrees Celsius (C) | Standard Deviation 0.06 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 9 Day 1 | -0.07 Degrees Celsius (C) | Standard Deviation 0.42 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 17 Day 1 | 0.00 Degrees Celsius (C) | Standard Deviation 60 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 2 Day 1 | 0.17 Degrees Celsius (C) | Standard Deviation 0.34 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 13 Day 1 | 0 Degrees Celsius (C) | — |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 18 Day 1 | -0.20 Degrees Celsius (C) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Baseline | 36.47 Degrees Celsius (C) | Standard Deviation 0.28 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 1 Day 15 | 0.18 Degrees Celsius (C) | Standard Deviation 0.32 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 10 Day 1 | 0.10 Degrees Celsius (C) | Standard Deviation 0.35 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 7 Day 1 | 0.20 Degrees Celsius (C) | Standard Deviation 0.26 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 1 Day 22 | 0.15 Degrees Celsius (C) | Standard Deviation 0.21 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 5 Day 1 | 0.10 Degrees Celsius (C) | Standard Deviation 0.32 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 19 Day 1 | 0 Degrees Celsius (C) | — |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 2 Day 15 | 0.23 Degrees Celsius (C) | Standard Deviation 0.38 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 11 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0.14 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 3 Day 1 | 0.17 Degrees Celsius (C) | Standard Deviation 0.43 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 20 Day 1 | 0 Degrees Celsius (C) | — |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 3 Day 15 | 0.10 Degrees Celsius (C) | Standard Deviation 0.26 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 4 Day 1 | 0.06 Degrees Celsius (C) | Standard Deviation 0.37 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 12 Day 1 | -0.20 Degrees Celsius (C) | Standard Deviation 0.14 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 8 Day 1 | 0.20 Degrees Celsius (C) | Standard Deviation 0.36 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 14 Day 1 | -0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 6 Day 1 | 0.12 Degrees Celsius (C) | Standard Deviation 0.16 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 15 Day 1 | -0.40 Degrees Celsius (C) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Final Visit | 0.08 Degrees Celsius (C) | Standard Deviation 0.37 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Oral Temperature | Cycle 16 Day 1 | -0.10 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 15 | -0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 20 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 6 Day 1 | -0.40 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 7 Day 1 | -0.60 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 21 Day 1 | -0.40 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 8 Day 1 | -0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 5 Day 1 | -0.80 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 9 Day 1 | -0.40 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 22 Day 1 | -0.70 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 10 Day 1 | -0.60 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 23 Day 1 | -0.80 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 11 Day 1 | -0.40 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 12 Day 1 | -0.70 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 13 Day 1 | -0.70 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 14 Day 1 | -0.70 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 15 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 16 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Final Visit | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 17 Day 1 | -0.80 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Baseline | 37.10 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 18 Day 1 | -0.80 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 15 | -0.30 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 2 Day 1 | -0.60 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 1 Day 22 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 19 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 4 Day 1 | -0.50 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 15 | -0.20 Degrees Celsius (C) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Oral Temperature | Cycle 3 Day 1 | 0.10 Degrees Celsius (C) | Standard Deviation 0 |
Secondary
Change From Baseline in Pulse Rate
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 5 Day 1 | 0.6 Beats per Minute | Standard Deviation 8.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 13, Day 1 | -2.8 Beats per Minute | Standard Deviation 7.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 11 Day 1 | -2.5 Beats per Minute | Standard Deviation 11.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 10 Day 1 | -0.3 Beats per Minute | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 6 Day 1 | 0.4 Beats per Minute | Standard Deviation 9.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 9 Day 1 | -5.4 Beats per Minute | Standard Deviation 6.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 8 Day 1 | -3.9 Beats per Minute | Standard Deviation 13.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 7 Day 1 | 1.4 Beats per Minute | Standard Deviation 14.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 22 | 3.9 Beats per Minute | Standard Deviation 11.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 1 | -2.8 Beats per Minute | Standard Deviation 9.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 1 | -1.1 Beats per Minute | Standard Deviation 8.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 14, Day 1 | -3.8 Beats per Minute | Standard Deviation 11.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 22, Day 1 | -8.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 15 | 0.1 Beats per Minute | Standard Deviation 11 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 15 | 4.5 Beats per Minute | Standard Deviation 13.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 21, Day 1 | 2.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 20, Day 1 | -5.0 Beats per Minute | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 19, Day 1 | -9.0 Beats per Minute | Standard Deviation 5.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 18, Day 1 | -4.3 Beats per Minute | Standard Deviation 3.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 15 | -1.2 Beats per Minute | Standard Deviation 9.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Final Visit | -1.7 Beats per Minute | Standard Deviation 12.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 17, Day 1 | -12.7 Beats per Minute | Standard Deviation 9.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 16 Day 1 | -1.3 Beats per Minute | Standard Deviation 15.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 4 Day 1 | 1.0 Beats per Minute | Standard Deviation 11.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Baseline | 74.7 Beats per Minute | Standard Deviation 12.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 15 Day 1 | -0.8 Beats per Minute | Standard Deviation 10.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Pulse Rate | Cycle 12, Day 1 | -0.2 Beats per Minute | Standard Deviation 11.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 4 Day 1 | 1.7 Beats per Minute | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Baseline | 71.6 Beats per Minute | Standard Deviation 9.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 15 | 5.4 Beats per Minute | Standard Deviation 5.5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 1 | 1.8 Beats per Minute | Standard Deviation 8.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 15 | 1.8 Beats per Minute | Standard Deviation 8.5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 15 | 10.8 Beats per Minute | Standard Deviation 13.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 5 Day 1 | -4.0 Beats per Minute | Standard Deviation 9.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 6 Day 1 | -4.3 Beats per Minute | Standard Deviation 6.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 7 Day 1 | 1.5 Beats per Minute | Standard Deviation 16.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 8 Day 1 | -1.0 Beats per Minute | Standard Deviation 12.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 9 Day 1 | 0.0 Beats per Minute | Standard Deviation 5.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 10 Day 1 | 8.5 Beats per Minute | Standard Deviation 19.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 14, Day 1 | -2.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 15 Day 1 | 10.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 16 Day 1 | -2.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 17, Day 1 | 9.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Final Visit | 0.2 Beats per Minute | Standard Deviation 11.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 22 | 8.2 Beats per Minute | Standard Deviation 4.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 1 | -2.0 Beats per Minute | Standard Deviation 8.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 11 Day 1 | -2.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 12, Day 1 | -6.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 13, Day 1 | -5.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Final Visit | 0.2 Beats per Minute | Standard Deviation 10.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 15 Day 1 | -2.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 1 Day 22 | -5.8 Beats per Minute | Standard Deviation 3.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 2 Day 1 | -9.3 Beats per Minute | Standard Deviation 6.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 11 Day 1 | 2.5 Beats per Minute | Standard Deviation 0.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 20, Day 1 | 4.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 3 Day 1 | -4.2 Beats per Minute | Standard Deviation 9.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 10 Day 1 | 2.3 Beats per Minute | Standard Deviation 8.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 19, Day 1 | 6.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 16 Day 1 | -2.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Baseline | 76.7 Beats per Minute | Standard Deviation 14.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 4 Day 1 | -6.6 Beats per Minute | Standard Deviation 9.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 12, Day 1 | -1.0 Beats per Minute | Standard Deviation 4.2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 7 Day 1 | -1.0 Beats per Minute | Standard Deviation 9.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 3 Day 15 | -2.2 Beats per Minute | Standard Deviation 11 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 6 Day 1 | -1.6 Beats per Minute | Standard Deviation 6.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 2 Day 15 | -5.8 Beats per Minute | Standard Deviation 5.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 8 Day 1 | 0.5 Beats per Minute | Standard Deviation 3.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 14, Day 1 | -4.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 1 Day 15 | -0.7 Beats per Minute | Standard Deviation 4.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 9 Day 1 | 0.3 Beats per Minute | Standard Deviation 2.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 17, Day 1 | 1.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 13, Day 1 | -1.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 18, Day 1 | -3.0 Beats per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Pulse Rate | Cycle 5 Day 1 | -3.6 Beats per Minute | Standard Deviation 4.2 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 9 Day 1 | 0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 5 Day 1 | 28.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Final Visit | 16.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 22 | 8.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 11 Day 1 | 37.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 4 Day 1 | 24.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 13, Day 1 | 16.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 14, Day 1 | 12.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Baseline | 68.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 15 | 21.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 16 Day 1 | 16.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 15 Day 1 | 14.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 17, Day 1 | 22.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 3 Day 1 | 9.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 19, Day 1 | 15.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 15 | 9.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 20, Day 1 | 5.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 21, Day 1 | 17.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 2 Day 1 | 12.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 22, Day 1 | 14 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 18, Day 1 | 16.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 1 Day 15 | 7.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 10 Day 1 | 20.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 23, Day 1 | 19.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 6 Day 1 | 14.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 7 Day 1 | 21.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 12, Day 1 | 21.0 Beats per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Pulse Rate | Cycle 8 Day 1 | 11.0 Beats per Minute | Standard Deviation 0 |
Secondary
Change From Baseline in Respiratory Rate
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 12 Day 1 | -0.4 Breaths per Minute | Standard Deviation 1.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 6 Day 1 | -0.5 Breaths per Minute | Standard Deviation 1.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 20 Day 1 | 2.0 Breaths per Minute | Standard Deviation 2.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 11 Day 1 | -0.8 Breaths per Minute | Standard Deviation 1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 10 Day 1 | -0.2 Breaths per Minute | Standard Deviation 1.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 7 Day 1 | -0.2 Breaths per Minute | Standard Deviation 1.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 9 Day 1 | 0.4 Breaths per Minute | Standard Deviation 1.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 8 Day 1 | 0.1 Breaths per Minute | Standard Deviation 1.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 18 Day 1 | 1.3 Breaths per Minute | Standard Deviation 2.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 15 | -0.2 Breaths per Minute | Standard Deviation 1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Final visit | -0.3 Breaths per Minute | Standard Deviation 1.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 17 Day 1 | 1.3 Breaths per Minute | Standard Deviation 2.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 16 Day 1 | -0.3 Breaths per Minute | Standard Deviation 1.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 1 | -0.7 Breaths per Minute | Standard Deviation 1.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 22 Day 1 | 0.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 1 | -0.3 Breaths per Minute | Standard Deviation 1.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Baseline | 17.4 Breaths per Minute | Standard Deviation 2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 15 | -0.7 Breaths per Minute | Standard Deviation 1.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 22 | -0.5 Breaths per Minute | Standard Deviation 0.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 21 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 19 Day 1 | 1.5 Breaths per Minute | Standard Deviation 2.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 4 Day 1 | -0.3 Breaths per Minute | Standard Deviation 1.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 15 Day 1 | 0.0 Breaths per Minute | Standard Deviation 1.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 14 Day 1 | 0.8 Breaths per Minute | Standard Deviation 2.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 5 Day 1 | -0.4 Breaths per Minute | Standard Deviation 1.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 15 | -0.3 Breaths per Minute | Standard Deviation 1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 13 Day 1 | -1.4 Breaths per Minute | Standard Deviation 2.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Final visit | -1.2 Breaths per Minute | Standard Deviation 1.5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 15 | -0.2 Breaths per Minute | Standard Deviation 1.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 1 | -0.3 Breaths per Minute | Standard Deviation 1.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 15 | 0.0 Breaths per Minute | Standard Deviation 0.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 1 | -1.5 Breaths per Minute | Standard Deviation 3.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 15 | 0.0 Breaths per Minute | Standard Deviation 1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 5 Day 1 | -0.3 Breaths per Minute | Standard Deviation 0.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 6 Day 1 | -0.5 Breaths per Minute | Standard Deviation 1.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 8 Day 1 | -0.5 Breaths per Minute | Standard Deviation 2.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 9 Day 1 | 0.5 Breaths per Minute | Standard Deviation 0.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 10 Day 1 | -0.5 Breaths per Minute | Standard Deviation 2.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 11 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 12 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 14 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 15 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Baseline | 17.4 Breaths per Minute | Standard Deviation 1.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 22 | 0.2 Breaths per Minute | Standard Deviation 0.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 4 Day 1 | -3.3 Breaths per Minute | Standard Deviation 4.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 7 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 13 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 16 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 17 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 8 Day 1 | -0.8 Breaths per Minute | Standard Deviation 3.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 18 Day 1 | -1.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 12 Day 1 | 1.5 Breaths per Minute | Standard Deviation 0.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 5 Day 1 | 1.0 Breaths per Minute | Standard Deviation 2.2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 14 Day 1 | 1.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 4 Day 1 | -1.0 Breaths per Minute | Standard Deviation 1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 2 Day 1 | -0.4 Breaths per Minute | Standard Deviation 1.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 15 Day 1 | -1.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 19 Day 1 | -3.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 3 Day 15 | -1.0 Breaths per Minute | Standard Deviation 1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Final visit | -1.8 Breaths per Minute | Standard Deviation 1.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 20 Day 1 | -3.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 1 Day 22 | -0.5 Breaths per Minute | Standard Deviation 2.2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 3 Day 1 | -1.8 Breaths per Minute | Standard Deviation 1.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 7 Day 1 | -2.3 Breaths per Minute | Standard Deviation 1.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 13 Day 1 | -1.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 1 Day 15 | -0.2 Breaths per Minute | Standard Deviation 1.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 16 Day 1 | -2.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 2 Day 15 | -1.2 Breaths per Minute | Standard Deviation 1.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Baseline | 18.2 Breaths per Minute | Standard Deviation 2.6 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 17 Day 1 | -2.0 Breaths per Minute | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 9 Day 1 | -1.7 Breaths per Minute | Standard Deviation 6 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 10 Day 1 | -0.3 Breaths per Minute | Standard Deviation 5.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 6 Day 1 | -0.6 Breaths per Minute | Standard Deviation 1.3 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Respiratory Rate | Cycle 11 Day 1 | -0.5 Breaths per Minute | Standard Deviation 0.7 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 20 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 11 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 22 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 8 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 5 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 1 Day 15 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 22 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 12 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 7 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 23 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 13 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 4 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 19 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 14 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 2 Day 15 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 10 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 15 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 18 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 15 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 9 Day 1 | -2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 16 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 21 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 6 Day 1 | 2.0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Final visit | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 3 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Cycle 17 Day 1 | 0 Breaths per Minute | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Respiratory Rate | Baseline | 16.0 Breaths per Minute | Standard Deviation 0 |
Secondary
Change From Baseline in Systolic Blood Pressure
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 13 Day 1 | 13.4 Millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 9 Day 1 | 12.6 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 12 Day 1 | 10.8 Millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 10 Day 1 | 11.8 Millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 22 Day 1 | 24.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 4, Day 1 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 9.1 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 21 Day 1 | -18.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Baseline | 129.3 Millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 19 Day 1 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 18 Day 1 | 5.7 Millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 7 Day 1 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 17 Day 1 | 9.3 Millimeters of mercury (mmHg) | Standard Deviation 5.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 11 Day 1 | 8.5 Millimeters of mercury (mmHg) | Standard Deviation 12.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2, Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 10.3 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 16 Day 1 | 7.5 Millimeters of mercury (mmHg) | Standard Deviation 8.6 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 15 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 14 Day 1 | 4.4 Millimeters of mercury (mmHg) | Standard Deviation 14.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Day 15 | 4.4 Millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 15 Day 1 | 13.6 Millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Days 22 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 9.4 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Final Visit | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 1 | 5.5 Millimeters of mercury (mmHg) | Standard Deviation 10.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2 , Day 15 | 5.2 Millimeters of mercury (mmHg) | Standard Deviation 9.8 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 5, Day 1 | 4.2 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 6 Day 1 | 11.2 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 8 Day 1 | 8.8 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Ruxolitinib-Naïve Participants With Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 20 Day 1 | 11.5 Millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 15 | -3.5 Millimeters of mercury (mmHg) | Standard Deviation 14.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2 , Day 15 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 13.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Days 22 | -5.6 Millimeters of mercury (mmHg) | Standard Deviation 11.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 5, Day 1 | -2.5 Millimeters of mercury (mmHg) | Standard Deviation 6.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 12 Day 1 | -8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 6 Day 1 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Day 15 | 3.6 Millimeters of mercury (mmHg) | Standard Deviation 13.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 14 Day 1 | 18.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 8 Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 7 Day 1 | -4.0 Millimeters of mercury (mmHg) | Standard Deviation 15.6 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Final Visit | 7.6 Millimeters of mercury (mmHg) | Standard Deviation 16.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 9 Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 1 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 9.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 17 Day 1 | 24.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 13 Day 1 | -8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 10 Day 1 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 2.8 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 16 Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2, Day 1 | 2.8 Millimeters of mercury (mmHg) | Standard Deviation 8.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 4, Day 1 | -7.3 Millimeters of mercury (mmHg) | Standard Deviation 9.3 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Baseline | 132.0 Millimeters of mercury (mmHg) | Standard Deviation 17.2 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 11 Day 1 | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 15 Day 1 | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Final Visit | 12.8 Millimeters of mercury (mmHg) | Standard Deviation 23.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Baseline | 122.3 Millimeters of mercury (mmHg) | Standard Deviation 16.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 1, Day 15 | 3.8 Millimeters of mercury (mmHg) | Standard Deviation 15.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 2, Day 1 | -4.3 Millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 2 , Day 15 | -7.2 Millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 4, Day 1 | 9.8 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 5, Day 1 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 6.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 7 Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 11 Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 12.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 13 Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 18 Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 1, Days 22 | 4.8 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 1 | 7.3 Millimeters of mercury (mmHg) | Standard Deviation 18.3 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 15 | -3.8 Millimeters of mercury (mmHg) | Standard Deviation 16.7 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 6 Day 1 | 8.6 Millimeters of mercury (mmHg) | Standard Deviation 10.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 8 Day 1 | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 18.8 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 9 Day 1 | -4.3 Millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 10 Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 13.2 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 12 Day 1 | 6.5 Millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 14 Day 1 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 15 Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 16 Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 17 Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 19 Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Total Ruxolitinib-Naïve Participants | Change From Baseline in Systolic Blood Pressure | Cycle 20 Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 13 Day 1 | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 22 Day 1 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 15 Day 1 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 11 Day 1 | 34.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 10 Day 1 | 30.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 23 Day 1 | 11.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 16 Day 1 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 8 Day 1 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 7 Day 1 | 29.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2, Day 1 | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 17 Day 1 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 6 Day 1 | 8.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 18 Day 1 | 13.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 5, Day 1 | 16.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Days 22 | -5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 19 Day 1 | 13.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 1, Day 15 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 20 Day 1 | 13.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 4, Day 1 | 13.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 21 Day 1 | 7.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 15 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 9 Day 1 | 26.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Final Visit | 19.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 12 Day 1 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 3, Day 1 | 0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 2 , Day 15 | 30.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Cycle 14 Day 1 | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Change From Baseline in Systolic Blood Pressure | Baseline | 106.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
Secondary
Clearance (CL) of Idasanutlin
CL is a measure of the body's elimination of a drug from plasma over time. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine CL as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28
Complete hematologic remission requires all of the following: Hct control without phlebotomy between Week 32 (Cycle 8 Day 28) and Cycle 11 Day 28; WBC count ≤10 × 10\^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%
Time frame: Week 32 (Cycle 8 Day 28), Cycle 11 Day 28
Population: ITT population. The number of participants analyzed is the number of patients (total n) per arm. The number analyzed was the number of patients evaluable at that specific timepoint. Not all participants of each arm were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Cycle 11, Day 28 | 2 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Week 32 | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Cycle 11, Day 28 | 1 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Week 32 | 2 Participants |
| Total Ruxolitinib-Naïve Participants | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Week 32 | 3 Participants |
| Total Ruxolitinib-Naïve Participants | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Cycle 11, Day 28 | 0 Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Cycle 11, Day 28 | 0 Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Duration of Complete Hematologic Remission, With a Durable Responder Defined as a Participant in Remission at Week 32 and Cycle 11 Day 28 | Week 32 | 0 Participants |
Secondary
Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time
The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all pre-disease activities without restriction), 1=Symptomatic but completely ambulatory, 2=Symptomatic, \< 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, \> 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Only baseline data were collectable. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the planned end of study.
Time frame: Baseline
Population: Safety-Evaluable Patients. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 0 | 66.7 Percentage of Participant |
| Ruxolitinib-Naïve Participants With Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 1 | 33.3 Percentage of Participant |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 0 | 60.0 Percentage of Participant |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 1 | 40.0 Percentage of Participant |
| Total Ruxolitinib-Naïve Participants | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 0 | 50.0 Percentage of Participant |
| Total Ruxolitinib-Naïve Participants | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 1 | 50.0 Percentage of Participant |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 1 | 0 Percentage of Participant |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time | Baseline 0 | 100.0 Percentage of Participant |
Secondary
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time
The PGIC is a one-item measure used to assess perceived treatment benefit. Participants were asked Since the start of the treatment you've received in this study, your polycythemia vera (PV) symptoms are: 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse'. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study.
Time frame: Cycle 2 Day 1, Cycle 3 Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and every 3 cycles thereafter (1 cycle is 28 days) until end of study (up to 2 years)
Population: ITT Population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Minimally Improved | 6 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 No Change | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Minimally Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Very Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Much Improved | 6 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Minimally Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 No Change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 No Change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Not Assessed | 4 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Very Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Minimally Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 No change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 No Change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Very Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Minimally Improved | 5 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Minimally Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Much Improved | 4 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 No Change | 6 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Very Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Very Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Minimally Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit No Change | 6 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Very Much Improved | 4 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Very Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Not Assessed | 2 Count of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Much Improved | 4 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 No Change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Minimally Worse | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Minimally Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 No Change | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Much Improved | 2 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Minimally Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Not Assessed | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Very Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Minimally Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 3 Day 28 Not Assessed | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Very Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Minimally Improved | 4 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 5 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Week 32 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 11 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 No change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 14 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Much Improved | 3 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 17 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Very Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Much Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Minimally Improved | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 No Change | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 20 Day 28 Not Assessed | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Very Much Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Minimally Improved | 1 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Minimally Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Final Visit Very Much Worse | 0 Count of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time | Cycle 2, Day 1 Much Improved | 1 Count of Participants |
Secondary
Half-life (t1/2) of Idasanutlin
t1/2 is defined as the time required for the drug plasma concentration to be reduced to half. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine t1/2 as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Maximum Serum Concentration Observed (Cmax) of Idasanutlin
Cmax is the maximum observed concentration of drug in blood. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine Cmax as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32
The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 2 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 2 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 2 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 0 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 0 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 0 Participants |
Secondary
Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32
The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 2 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 4 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 2 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Durable Response, in Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
Secondary
Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32
The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 5 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 6 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 4 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 2 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 3 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Number of Participants With a Duration Response, in All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Participants |
Secondary
Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria
Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study.
Time frame: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
Population: ITT population. The number of participants analyzed is the number of patients (total n) per arm. The number analyzed was the number of patients evaluable at that specific timepoint. Not all participants of each arm were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Complete Response | 14.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Complete Response | 10.5 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Partial Response | 68.4 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 No Response | 21.1 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Partial Response | 68.8 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 No Response | 18.8 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 18.2 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 54.5 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) No Response | 27.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Complete Response | 16.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Partial Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 No Response | 16.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Complete Response | 16.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Partial Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 No Response | 16.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Complete Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Partial Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 No Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Partial Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Partial Response | 21.4 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit No Response | 64.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Complete Response | 12.5 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 12 Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 12 Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Partial Response | 50 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Complete Response | 28.6 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Partial Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 No Response | 28.6 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 Partial Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 5, Day 28 No Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 20.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 17, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 40.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Final Visit No Response | 75.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) No Response | 40.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 14, Day 28 No Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Partial Response | 42.9 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 Partial Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 20, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 11 Day 28 No Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 12 Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) by Response Per Modified ELN Criteria | Cycle 12 Day 28 Partial Response | 100 Percentage of Participants |
Secondary
Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32
The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 Complete Hematologic Response | 44.4 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 ELN Response | 60 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 HCT Control | 55.6 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 ELN Response | 60 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 HCT Control | 75 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants (Irrespective of Spleen Size) With Durable Response Lasting at Least 12 Weeks From Week 32 | After 12 Weeks from Week 32 Complete Hematologic Response | 50 Percentage of Participants |
Secondary
Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28
Complete hematologic remission requires all of the following: Hct control without phlebotomy between Weeks 32 and Cycle 11 Day 28; WBC count ≤10 × 10\^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%.
Time frame: Cycle 11 Day 28
Population: ITT Population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28 | 40 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28 | 100 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28 | 0 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Remission at Cycle 11 Day 28 | 0 Percentage of Participants |
Secondary
Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32
Complete hematologic response requires all of the following: Hct control without phlebotomy; White blood cell (WBC) count ≤10 × 10\^9/Liter (L) at Week 32; and Platelet count ≤400 × 10\^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of \>48%.
Time frame: Week 32 (Cycle 8 Day 28)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32 | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32 | 100 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32 | 75.0 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32 | 0 Percentage of Participants |
Secondary
Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters
Clinical chemistry parameter laboratory values falling outside the standard reference range were to be recorded as either high or low. There was no clinical chemistry abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study.
Time frame: Baseline to end of study (up to 2 years)
Population: Safety-Evaluable Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters | 0 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters | 0 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters | 0 Percentage of Participants |
Secondary
Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters.
Hematology parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low. There was no clinical laboratory abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study.
Time frame: Baseline to end of study (up to 2 years)
Population: Safety-Evaluable Patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters. | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters. | 0 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters. | 0 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters. | 0 Percentage of Participants |
Secondary
Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters
Urinalysis parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low. There was no clinical laboratory (urinalysis) abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study.
Time frame: Baseline to end of study (up to 2 years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters | 0 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters | 0 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters | 0 Percentage of Participants |
Secondary
Percentage of Participants With Concomitant Medications
Participants with Concomitant Medications used from 28 days prior to screening until the final visit or end of study (EOS) were reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Overall Study Period
Population: Safety-Evaluable Population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Participants With Concomitant Medications | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Participants With Concomitant Medications | 100 Percentage of Participants |
| Total Ruxolitinib-Naïve Participants | Percentage of Participants With Concomitant Medications | 100 Percentage of Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Percentage of Participants With Concomitant Medications | 100 Percentage of Participants |
Secondary
Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria
Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study.
Time frame: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
Population: ITT population. The number of participants analyzed is the number of patients (total n) per arm. The number analyzed was the number of patients evaluable at that specific timepoint. Not all participants of each arm were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Progressive Disease | 0.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) No Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Partial Response | 50 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Complete Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Partial Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Complete Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Partial Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Complete Response | 50 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Complete Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Complete Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Complete Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 8, Day 28 (Week 32) No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 14, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 20, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 20, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 20, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 20, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 3, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 5 Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 11, day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Cycle 17, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline by Response Per Modified ELN Criteria | Final (28 Days post-last dose) Partial Response | 0 Percentage of Participants |
Secondary
Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32
The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 0 Percentage of Participants |
Secondary
Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria
Complete response (CR) includes all of the following: Hct \<45% without phlebotomy; Platelet count ≤400 × 10\^9/L; WBC count ≤10 × 10\^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct \<45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia. All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study.
Time frame: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
Population: ITT population. The number of participants analyzed is the number of patients (total n) per arm. The number analyzed was the number of patients evaluable at that specific timepoint. Not all participants of each arm were evaluable at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 No Response | 26.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) No Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Partial Response | 80.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 No Response | 20.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Partial Response | 73.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 No Response | 23.1 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Partial Response | 80 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 No Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 No Response | 20 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 20, Day 28 Partial Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 20, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Partial Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Partial Response | 76.9 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 20, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 20, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Partial Response | 20.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) No Response | 80 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 No Response | 20.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 12, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) No Response | 66.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Baseline No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Partial Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 No Response | 16.7 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 5, Day 28 Partial Response | 80.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 3, Day 28 Complete Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Complete Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) Partial Response | 50.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 8, Day 28 (Week 32) No Response | 25.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 Partial Response | 100.0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 11, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 12, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 12, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 12, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Partial Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 14, Day 28 No Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Complete Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Partial Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 Progressive Disease | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Cycle 17, Day 28 No Response | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Partial Response | 33.3 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline by Response Per Modified European Leukemia Net (ELN) Criteria | Final Visit (28 Days post-last dose) Progressive Disease | 0 Percentage of Participants |
Secondary
Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32
The percentage of participants with a durable response lasting at least 12 weeks from Week 32 are analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable. Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study.
Time frame: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 28.6 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 50 Percentage of Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 42.9 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Composite Response | 0 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | HCT Control | 100 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | ELN Response | 75 Percentage of Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Percentage of Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly at Baseline With Durable Response Lasting at Least 12 Weeks From Week 32 | Complete Hematologic Response | 66.7 Percentage of Participants |
Secondary
Time of Maximum Concentration Observed (Tmax) of Idasanutlin
Tmax is the time elapsed from the time of drug administration to maximum plasma concentration. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine tmax as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. The adverse event severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity. During the final analyses, the focus was on the Adverse Events of severity grades \>/=3 as shown below. The extensive listings of all grade AEs are available at request. The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study.
Time frame: Baseline to end of study (up to 2 years)
Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Baseline | 0 Participants |
| Ruxolitinib-Naïve Participants With Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Grade 3-5 AE | 5 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Grade 3-5 AE | 2 Participants |
| Ruxolitinib-Naïve Participants Without Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Baseline | 0 Participants |
| Total Ruxolitinib-Naïve Participants | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Baseline | 0 Participants |
| Total Ruxolitinib-Naïve Participants | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Grade 3-5 AE | 3 Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Grade 3-5 AE | 0 Participants |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 | Baseline | 0 Participants |
Secondary
Trough Concentration (Ctrough) of Idasanutlin
Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine Ctrough as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.
Secondary
Volume or Apparent Volume of Distribution (Vdss/F) of Idasanutlin
Vdss/F is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the plasma. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Time frame: Days 1, 2, and 5 of Cycles 1 and 4
Population: The study plan was to determine Vdss/F as part of the pharmacokinetics, however study was terminated prematurely in the initial phase after 27 patients were recruited due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity leading to high dropout rate in participants. Therefore, no participants were available for this endpoint and result data were not collected.