Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera (NCT NCT03287245)

Last Updated: 2021-12-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Week 32

Results posted on

2021-12-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).	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).	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)	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)
Overall Study STARTED	15	5	6	1
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	15	5	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).	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)	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)
Overall Study Study terminated by sponsor	3	0	3	1
Overall Study Adverse Event	1	0	0	0
Overall Study Withdrawal by Subject	8	3	3	0
Overall Study Physician Decision	3	2	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib-naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-naïve Participants Without Splenomegaly n=5 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly n=6 Participants 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)	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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)	Total n=27 Participants Total of all reporting groups
Age, Continuous	54.5 Years STANDARD_DEVIATION 10.7 • n=5 Participants	56.8 Years STANDARD_DEVIATION 8.8 • n=7 Participants	60.3 Years STANDARD_DEVIATION 8.4 • n=5 Participants	55 Years STANDARD_DEVIATION 0 • n=4 Participants	56.3 Years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	14 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	26 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	26 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 32

Population: ITT Population

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=9 Participants 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).	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).	Total Ruxolitinib-Naïve Participants 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).	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).
Percentage of Ruxolitinib-Naïve Participants With Splenomegaly at Baseline Who Achieved Composite Response at Week 32	44.4 Percentage of Participants	—	—	—

PRIMARY outcome

Timeframe: Week 32

Population: ITT Population

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%.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=2 Participants 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).	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).	Total Ruxolitinib-Naïve Participants 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).	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).
Percentage of Ruxolitinib-Naïve Participants Without Splenomegaly at Baseline Who Achieved Hematocrit (Hct) Control Without Phlebotomy at Week 32	100 Percentage of Participants	—	—	—

PRIMARY outcome

Timeframe: Week 32

Population: ITT population

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=9 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=2 Participants 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).	Total Ruxolitinib-Naïve Participants n=11 Participants 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).	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).
Percentage of All Ruxolitinib-Naïve Participants (Irrespective of Spleen Size) Who Achieved Hct Control Without Phlebotomy at Week 32	44.4 Percentage of Participants	100 Percentage of Participants	54.5 Percentage of Participants	—

PRIMARY outcome

Timeframe: From Baseline to Week 32 (Cycle 8 Day 28)

Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=4 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=1 Participants 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).	Total Ruxolitinib-Naïve Participants n=5 Participants 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).	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).
Percentage of All Ruxolitinib-Resistant or Intolerant Participants Who Achieved Hct Control Without Phlebotomy at Week 32	75.0 Percentage of Participants	0 Percentage of Participants	60 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 32 (Cycle 8 Day 28)

Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.

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%.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=9 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=2 Participants 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).	Total Ruxolitinib-Naïve Participants n=4 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Percentage of All Ruxolitinib-Naïve and Ruxolitinib-Resistant or Intolerant Participants Who Achieved Complete Hematologic Response at Week 32	33.3 Percentage of Participants	100 Percentage of Participants	75.0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Cycle 11 Day 28

Population: ITT Population. The number analyzed includes participants who were evaluable at each timepoint.

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%.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=5 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=1 Participants 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).	Total Ruxolitinib-Naïve Participants n=1 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
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	100 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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%

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
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	1 Participants	0 Participants	0 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	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=6 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	33.3 Percentage of Participants	—	—
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	50.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	16.7 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	80.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	20.0 Percentage of Participants	—	—
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	25.0 Percentage of Participants	—	—
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	50.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	25.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	—	—
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	—	—
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	—	—
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	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	0 Percentage of Participants	—	—
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	33.3 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	66.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=5 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=1 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	—	—
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	—	—
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	—	—
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	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	28.6 Percentage of Participants	—	—
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	42.9 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	28.6 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	66.7 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	33.3 Percentage of Participants	—	—
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	20.0 Percentage of Participants	—	—
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	40.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	40.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	50.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	50.0 Percentage of Participants	—	—
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	—	—
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	—	—
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	—	—
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	—	—
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	0 Percentage of Participants	—	—
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	50 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	50.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	25.0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	75.0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=6 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	100 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	75 Percentage of Participants	—	—
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	66.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=6 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	3 Participants	—	—
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	0 Participants	—	—
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	3 Participants	—	—
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	2 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=5 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=1 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=5 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=1 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	75 Percentage of Participants	—	—
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	0 Percentage of Participants	—	—
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	60 Percentage of Participants	—	—
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	50 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	3 Participants	—	—
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	0 Participants	—	—
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	3 Participants	—	—
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	2 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to end of study (up to 2 years)

Population: ITT population. The number analyzed includes participants who were evaluable at each timepoint.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 Grade 3-5 AE	5 Participants	2 Participants	3 Participants	0 Participants
Total Number of Participants With Adverse Events by Severity, Graded According to NCI CTCAE v4.0 Baseline	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to end of study (up to 2 years)

Population: Safety-Evaluable Patients.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Percentage of Participants With Clinical Laboratory Abnormalities: Hematology Parameters.	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to end of study (up to 2 years)

Population: Safety-Evaluable Participants

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Percentage of Participants With Clinical Laboratory Abnormalities: Clinical Chemistry Parameters	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to end of study (up to 2 years)

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Percentage of Participants With Clinical Laboratory Abnormalities: Urinalysis Parameters	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

SECONDARY outcome

Population: Safety-Evaluable Participants. The number analyzed includes participants who were evaluable at each timepoint.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Baseline	71.47 Beats per Minute Standard Deviation 12.74	69.80 Beats per Minute Standard Deviation 12.28	73.17 Beats per Minute Standard Deviation 10.07	77.00 Beats per Minute Standard Deviation 0
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	0.60 Beats per Minute Standard Deviation 5.32	2.50 Beats per Minute Standard Deviation 4.23	-21.00 Beats per Minute Standard Deviation 0
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	-0.60 Beats per Minute Standard Deviation 8.65	3.00 Beats per Minute Standard Deviation 5.44	-11.00 Beats per Minute Standard Deviation 0
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 1 Day 2, pre-dose	-3.00 Beats per Minute Standard Deviation 0	-1.00 Beats per Minute Standard Deviation 0	—	—
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	-1.75 Beats per Minute Standard Deviation 5.32	-0.67 Beats per Minute Standard Deviation 2.50	-5.00 Beats per Minute Standard Deviation 0
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	-0.75 Beats per Minute Standard Deviation 8.14	-5.60 Beats per Minute Standard Deviation 5.27	-4.00 Beats per Minute Standard Deviation 0
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	-5.00 Beats per Minute Standard Deviation 2.94	-2.20 Beats per Minute Standard Deviation 7.92	5.00 Beats per Minute Standard Deviation 0
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	-3.75 Beats per Minute Standard Deviation 7.76	-2.80 Beats per Minute Standard Deviation 4.92	6.00 Beats per Minute Standard Deviation 0
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	-1.50 Beats per Minute Standard Deviation 8.39	-6.17 Beats per Minute Standard Deviation 5.19	-12.00 Beats per Minute Standard Deviation 0
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 3 Day 1, pre-dose	-5.00 Beats per Minute Standard Deviation 0	—	—	—
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 3 Day 1, 4 hour	7.00 Beats per Minute Standard Deviation 0	—	—	—
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 3 Day 1, 6 hour	5.00 Beats per Minute Standard Deviation 0	—	—	—
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 4 Day 1, pre-dose	-16.00 Beats per Minute Standard Deviation 0	—	—	—
Change From Baseline in Heart Rate, as Measured by Electrocardiogram Cycle 4 Day 1, 4 hour	-16.00 Beats per Minute Standard Deviation 0	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: Baseline

Population: Safety-Evaluable Patients. The number analyzed includes participants who were evaluable at each timepoint.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time Baseline 0	66.7 Percentage of Participant	60.0 Percentage of Participant	50.0 Percentage of Participant	100.0 Percentage of Participant
Eastern Cooperative Oncology Group (ECOG) Performance Status Over Time Baseline 1	33.3 Percentage of Participant	40.0 Percentage of Participant	50.0 Percentage of Participant	0 Percentage of Participant

SECONDARY outcome

Timeframe: Overall Study Period

Population: Safety-Evaluable Population. The number analyzed includes participants who were evaluable at each timepoint.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Percentage of Participants With Concomitant Medications	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	26.00 Score on a Scale Standard Deviation 11.83	—	—
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	0.80 Score on a Scale Standard Deviation 26.37	—	—
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	-8.00 Score on a Scale Standard Deviation 15.08	—	—
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	-9.50 Score on a Scale Standard Deviation 10.56	—	—
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	-5.00 Score on a Scale Standard Deviation 15.26	—	—
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	-7.50 Score on a Scale Standard Deviation 3.54	—	—
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	-10.50 Score on a Scale Standard Deviation 4.95	—	—
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	-12.00 Score on a Scale Standard Deviation 1.41	—	—
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	-8.00 Score on a Scale Standard Deviation 0	—	—
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	-7.20 Score on a Scale Standard Deviation 5.63	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	76.19 Score on a Scale Standard Deviation 30.21	—	—
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	8.33 Score on a Scale Standard Deviation 13.94	—	—
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	6.67 Score on a Scale Standard Deviation 19.00	—	—
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	11.11 Score on a Scale Standard Deviation 25.09	—	—
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	-3.33 Score on a Scale Standard Deviation 21.73	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	-8.33 Score on a Scale Standard Deviation 11.79	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	6.67 Score on a Scale Standard Deviation 9.13	—	—
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	14.29 Score on a Scale Standard Deviation 17.82	—	—
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	5.56 Score on a Scale Standard Deviation 13.61	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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 19.30	5.56 Score on a Scale Standard Deviation 13.61	—	—
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	20.00 Score on a Scale Standard Deviation 18.26	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	6.67 Score on a Scale Standard Deviation 14.91	—	—
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	64.29 Score on a Scale Standard Deviation 21.36	—	—
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	15.28 Score on a Scale Standard Deviation 13.35	—	—
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	8.33 Score on a Scale Standard Deviation 10.21	—	—
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	6.94 Score on a Scale Standard Deviation 16.17	—	—
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	5.00 Score on a Scale Standard Deviation 27.39	—	—
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	16.67 Score on a Scale Standard Deviation 0	—	—
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	-4.17 Score on a Scale Standard Deviation 5.89	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	8.33 Score on a Scale Standard Deviation 0	—	—
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	16.67 Score on a Scale Standard Deviation 18.63	—	—
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	2.38 Score on a Scale Standard Deviation 6.30	—	—
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	8.33 Score on a Scale Standard Deviation 22.97	—	—
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	3.33 Score on a Scale Standard Deviation 13.94	—	—
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	8.33 Score on a Scale Standard Deviation 17.48	—	—
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	16.67 Score on a Scale Standard Deviation 16.67	—	—
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	0.00 Score on a Scale Standard Deviation 23.57	—	—
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 6.80	-8.33 Score on a Scale Standard Deviation 11.79	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	6.67 Score on a Scale Standard Deviation 19.00	—	—
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	76.19 Score on a Scale Standard Deviation 13.11	—	—
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	0.00 Score on a Scale Standard Deviation 10.54	—	—
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	3.33 Score on a Scale Standard Deviation 13.94	—	—
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	-2.78 Score on a Scale Standard Deviation 26.70	—	—
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	-6.67 Score on a Scale Standard Deviation 19.00	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	-6.67 Score on a Scale Standard Deviation 25.28	—	—
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	81.90 Score on a Scale Standard Deviation 11.36	—	—
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	2.22 Score on a Scale Standard Deviation 6.89	—	—
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	2.67 Score on a Scale Standard Deviation 5.96	—	—
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	-2.22 Score on a Scale Standard Deviation 5.44	—	—
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	-4.00 Score on a Scale Standard Deviation 7.60	—	—
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	-10.00 Score on a Scale Standard Deviation 14.14	—	—
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	0.00 Score on a Scale Standard Deviation 9.43	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	-2.67 Score on a Scale Standard Deviation 7.60	—	—
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	60.71 Score on a Scale Standard Deviation 7.93	—	—
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	1.39 Score on a Scale Standard Deviation 8.19	—	—
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	11.67 Score on a Scale Standard Deviation 9.50	—	—
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	0.00 Score on a Scale Standard Deviation 17.48	—	—
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	-8.33 Score on a Scale Standard Deviation 13.18	—	—
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	8.33 Score on a Scale Standard Deviation 11.79	—	—
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	8.33 Score on a Scale Standard Deviation 0	—	—
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	16.67 Score on a Scale Standard Deviation 0	—	—
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	25.00 Score on a Scale Standard Deviation 0	—	—
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	13.33 Score on a Scale Standard Deviation 17.28	—	—
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	76.19 Score on a Scale Standard Deviation 16.27	—	—
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	-8.33 Score on a Scale Standard Deviation 17.48	—	—
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 17.80	0.00 Score on a Scale Standard Deviation 11.79	—	—
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	-2.78 Score on a Scale Standard Deviation 22.15	—	—
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	0.00 Score on a Scale Standard Deviation 20.41	—	—
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	-8.33 Score on a Scale Standard Deviation 11.79	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	0 Score on a Scale Standard Deviation 0	—	—
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	6.67 Score on a Scale Standard Deviation 9.13	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=20 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=7 Participants 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).	Total Ruxolitinib-Naïve Participants 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).	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).
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	0 Count of Participants	—	—
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	1 Count of Participants	—	—
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	3 Count of Participants	—	—
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	1 Count of Participants	—	—
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	1 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	1 Count of Participants	—	—
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	1 Count of Participants	—	—
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	1 Count of Participants	—	—
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	3 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	1 Count of Participants	—	—
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	1 Count of Participants	—	—
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	1 Count of Participants	—	—
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	4 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 Much Improved	3 Count of Participants	1 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 Minimally Improved	3 Count of Participants	3 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 No Change	1 Count of Participants	1 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 Minimally Worse	1 Count of Participants	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 Much Worse	0 Count of Participants	0 Count of Participants	—	—
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	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Week 32 Not Assessed	0 Count of Participants	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	2 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	2 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	2 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	0 Count of Participants	—	—
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	1 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit Much Improved	3 Count of Participants	3 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit Minimally Improved	2 Count of Participants	1 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit No Change	6 Count of Participants	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit Minimally Worse	1 Count of Participants	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit Much Worse	0 Count of Participants	0 Count of Participants	—	—
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	0 Count of Participants	—	—
Frequency Count of Participant Responses to the Patient Global Impression of Change (PGIC) Question Over Time Final Visit Not Assessed	2 Count of Participants	0 Count of Participants	—	—

Adverse Events

Ruxolitinib Naive-With Splenomegaly

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Ruxolitinib Naive-Without Splenomegaly

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ruxolitinib Naive-With Splenomegaly n=15 participants at risk 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).	Ruxolitinib Naive-Without Splenomegaly n=5 participants at risk 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).	Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly n=6 participants at risk 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 participants at risk 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).
Cardiac disorders Atrial fibrillation	6.7% 1/15 • Number of events 1 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/5 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/6 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/1 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.
Cardiac disorders Atrial flutter	6.7% 1/15 • Number of events 2 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/5 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/6 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/1 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/15 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	20.0% 1/5 • Number of events 1 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/6 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.	0.00% 0/1 • From Baseline to end of study (up to 2 years) post initial dose or until subject discontinued. Safety follow-up: Until 28 days after the last dose of study treatment or until initiating another anti-cancer therapy. Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold.

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Oral Temperature Baseline	36.50 Degrees Celsius (C) Standard Deviation 0.37	36.40 Degrees Celsius (C) Standard Deviation 0.25	36.47 Degrees Celsius (C) Standard Deviation 0.28	37.10 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 1 Day 15	0.13 Degrees Celsius (C) Standard Deviation 0.33	0.42 Degrees Celsius (C) Standard Deviation 0.50	0.18 Degrees Celsius (C) Standard Deviation 0.32	-0.30 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 1 Day 22	0.03 Degrees Celsius (C) Standard Deviation 0.18	0.04 Degrees Celsius (C) Standard Deviation 0.29	0.15 Degrees Celsius (C) Standard Deviation 0.21	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 2 Day 1	-0.05 Degrees Celsius (C) Standard Deviation 0.28	0.05 Degrees Celsius (C) Standard Deviation 0.30	0.17 Degrees Celsius (C) Standard Deviation 0.34	-0.60 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 2 Day 15	0.04 Degrees Celsius (C) Standard Deviation 0.27	0.18 Degrees Celsius (C) Standard Deviation 0.24	0.23 Degrees Celsius (C) Standard Deviation 0.38	-0.30 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 3 Day 1	-0.09 Degrees Celsius (C) Standard Deviation 0.36	0.13 Degrees Celsius (C) Standard Deviation 0.45	0.17 Degrees Celsius (C) Standard Deviation 0.43	0.10 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 3 Day 15	-0.04 Degrees Celsius (C) Standard Deviation 0.31	-0.03 Degrees Celsius (C) Standard Deviation 0.06	0.10 Degrees Celsius (C) Standard Deviation 0.26	-0.20 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 4 Day 1	-0.05 Degrees Celsius (C) Standard Deviation 0.26	-0.17 Degrees Celsius (C) Standard Deviation 0.15	0.06 Degrees Celsius (C) Standard Deviation 0.37	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 5 Day 1	0.05 Degrees Celsius (C) Standard Deviation 0.16	-0.10 Degrees Celsius (C) Standard Deviation 0.36	0.10 Degrees Celsius (C) Standard Deviation 0.32	-0.80 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 6 Day 1	-0.03 Degrees Celsius (C) Standard Deviation 0.16	-0.10 Degrees Celsius (C) Standard Deviation 0.45	0.12 Degrees Celsius (C) Standard Deviation 0.16	-0.40 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 7 Day 1	0.01 Degrees Celsius (C) Standard Deviation 0.30	-0.20 Degrees Celsius (C) Standard Deviation 0.28	0.20 Degrees Celsius (C) Standard Deviation 0.26	-0.60 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 8 Day 1	-0.01 Degrees Celsius (C) Standard Deviation 0.20	-0.05 Degrees Celsius (C) Standard Deviation 0.64	0.20 Degrees Celsius (C) Standard Deviation 0.36	-0.30 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 9 Day 1	0.03 Degrees Celsius (C) Standard Deviation 0.13	0.05 Degrees Celsius (C) Standard Deviation 0.35	-0.07 Degrees Celsius (C) Standard Deviation 0.42	-0.40 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 10 Day 1	-0.08 Degrees Celsius (C) Standard Deviation 0.10	0.30 Degrees Celsius (C) Standard Deviation 0.42	0.10 Degrees Celsius (C) Standard Deviation 0.35	-0.60 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 11 Day 1	-0.07 Degrees Celsius (C) Standard Deviation 0.19	-0.20 Degrees Celsius (C) Standard Deviation 0	-0.10 Degrees Celsius (C) Standard Deviation 0.14	-0.40 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 12 Day 1	-0.10 Degrees Celsius (C) Standard Deviation 0.16	0.30 Degrees Celsius (C) Standard Deviation 0	-0.20 Degrees Celsius (C) Standard Deviation 0.14	-0.70 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 13 Day 1	0.00 Degrees Celsius (C) Standard Deviation 0.19	-0.70 Degrees Celsius (C) Standard Deviation 0	0 Degrees Celsius (C)	-0.70 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 14 Day 1	0.00 Degrees Celsius (C) Standard Deviation 0.41	-0.10 Degrees Celsius (C) Standard Deviation 0	-0.30 Degrees Celsius (C) Standard Deviation 0	-0.70 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 15 Day 1	-0.10 Degrees Celsius (C) Standard Deviation 0.14	-0.30 Degrees Celsius (C) Standard Deviation 0	-0.40 Degrees Celsius (C) Standard Deviation 0	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 16 Day 1	0.03 Degrees Celsius (C) Standard Deviation 0.30	-0.80 Degrees Celsius (C) Standard Deviation 0	-0.10 Degrees Celsius (C) Standard Deviation 0	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 17 Day 1	0.03 Degrees Celsius (C) Standard Deviation 0.12	0.60 Degrees Celsius (C) Standard Deviation 0	0.00 Degrees Celsius (C) Standard Deviation 60	-0.80 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 18 Day 1	0.07 Degrees Celsius (C) Standard Deviation 0.15	—	-0.20 Degrees Celsius (C) Standard Deviation 0	-0.80 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 19 Day 1	-0.15 Degrees Celsius (C) Standard Deviation 0.21	—	0 Degrees Celsius (C)	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 20 Day 1	0.00 Degrees Celsius (C) Standard Deviation 0.14	—	0 Degrees Celsius (C)	-0.50 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 21 Day 1	0 Degrees Celsius (C) Standard Deviation 0	—	—	-0.40 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 22 Day 1	-0.50 Degrees Celsius (C) Standard Deviation 0	—	—	-0.70 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Cycle 23 Day 1	—	—	—	-0.80 Degrees Celsius (C) Standard Deviation 0
Change From Baseline in Oral Temperature Final Visit	-0.08 Degrees Celsius (C) Standard Deviation 0.15	0.26 Degrees Celsius (C) Standard Deviation 0.26	0.08 Degrees Celsius (C) Standard Deviation 0.37	-0.50 Degrees Celsius (C) Standard Deviation 0

Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Pulse Rate Cycle 9 Day 1	-5.4 Beats per Minute Standard Deviation 6.4	0.0 Beats per Minute Standard Deviation 5.7	0.3 Beats per Minute Standard Deviation 2.5	0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 8 Day 1	-3.9 Beats per Minute Standard Deviation 13.3	-1.0 Beats per Minute Standard Deviation 12.7	0.5 Beats per Minute Standard Deviation 3.1	11.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Baseline	74.7 Beats per Minute Standard Deviation 12.3	71.6 Beats per Minute Standard Deviation 9.2	76.7 Beats per Minute Standard Deviation 14.1	68.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 1 Day 15	4.5 Beats per Minute Standard Deviation 13.2	5.4 Beats per Minute Standard Deviation 5.5	-0.7 Beats per Minute Standard Deviation 4.8	7.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 1 Day 22	3.9 Beats per Minute Standard Deviation 11.3	8.2 Beats per Minute Standard Deviation 4.9	-5.8 Beats per Minute Standard Deviation 3.9	8.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 2 Day 1	-1.1 Beats per Minute Standard Deviation 8.6	1.8 Beats per Minute Standard Deviation 8.7	-9.3 Beats per Minute Standard Deviation 6.1	12.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 2 Day 15	0.1 Beats per Minute Standard Deviation 11.0	1.8 Beats per Minute Standard Deviation 8.5	-5.8 Beats per Minute Standard Deviation 5.5	9.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 3 Day 1	-2.8 Beats per Minute Standard Deviation 9.4	-2.0 Beats per Minute Standard Deviation 8.6	-4.2 Beats per Minute Standard Deviation 9.9	9.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 3 Day 15	-1.2 Beats per Minute Standard Deviation 9.7	10.8 Beats per Minute Standard Deviation 13.6	-2.2 Beats per Minute Standard Deviation 11.0	21.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 4 Day 1	1.0 Beats per Minute Standard Deviation 11.2	1.7 Beats per Minute Standard Deviation 9.9	-6.6 Beats per Minute Standard Deviation 9.8	24.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 5 Day 1	0.6 Beats per Minute Standard Deviation 8.4	-4.0 Beats per Minute Standard Deviation 9.3	-3.6 Beats per Minute Standard Deviation 4.2	28.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 6 Day 1	0.4 Beats per Minute Standard Deviation 9.1	-4.3 Beats per Minute Standard Deviation 6.8	-1.6 Beats per Minute Standard Deviation 6.8	14.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 7 Day 1	1.4 Beats per Minute Standard Deviation 14.6	1.5 Beats per Minute Standard Deviation 16.3	-1.0 Beats per Minute Standard Deviation 9.8	21.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 10 Day 1	-0.3 Beats per Minute Standard Deviation 9.9	8.5 Beats per Minute Standard Deviation 19.1	2.3 Beats per Minute Standard Deviation 8.5	20.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 11 Day 1	-2.5 Beats per Minute Standard Deviation 11.5	-2.0 Beats per Minute Standard Deviation 0	2.5 Beats per Minute Standard Deviation 0.7	37.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 12, Day 1	-0.2 Beats per Minute Standard Deviation 11.6	-6.0 Beats per Minute Standard Deviation 0	-1.0 Beats per Minute Standard Deviation 4.2	21.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 13, Day 1	-2.8 Beats per Minute Standard Deviation 7.8	-5.0 Beats per Minute Standard Deviation 0	-1.0 Beats per Minute Standard Deviation 0	16.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 14, Day 1	-3.8 Beats per Minute Standard Deviation 11.1	-2.0 Beats per Minute Standard Deviation 0	-4.0 Beats per Minute Standard Deviation 0	12.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 15 Day 1	-0.8 Beats per Minute Standard Deviation 10.4	10.0 Beats per Minute Standard Deviation 0	-2.0 Beats per Minute Standard Deviation 0	14.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 16 Day 1	-1.3 Beats per Minute Standard Deviation 15.6	-2.0 Beats per Minute Standard Deviation 0	-2.0 Beats per Minute Standard Deviation 0	16.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 17, Day 1	-12.7 Beats per Minute Standard Deviation 9.5	9.0 Beats per Minute Standard Deviation 0	1.0 Beats per Minute Standard Deviation 0	22.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 18, Day 1	-4.3 Beats per Minute Standard Deviation 3.5	—	-3.0 Beats per Minute Standard Deviation 0	16.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 19, Day 1	-9.0 Beats per Minute Standard Deviation 5.7	—	6.0 Beats per Minute Standard Deviation 0	15.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 20, Day 1	-5.0 Beats per Minute Standard Deviation 9.9	—	4.0 Beats per Minute Standard Deviation 0	5.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 21, Day 1	2.0 Beats per Minute Standard Deviation 0	—	—	17.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 22, Day 1	-8.0 Beats per Minute Standard Deviation 0	—	—	14 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Cycle 23, Day 1	—	—	—	19.0 Beats per Minute Standard Deviation 0
Change From Baseline in Pulse Rate Final Visit	-1.7 Beats per Minute Standard Deviation 12.2	0.2 Beats per Minute Standard Deviation 11.6	0.2 Beats per Minute Standard Deviation 10.1	16.0 Beats per Minute Standard Deviation 0

Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Respiratory Rate Cycle 8 Day 1	0.1 Breaths per Minute Standard Deviation 1.5	-0.5 Breaths per Minute Standard Deviation 2.1	-0.8 Breaths per Minute Standard Deviation 3.8	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 9 Day 1	0.4 Breaths per Minute Standard Deviation 1.8	0.5 Breaths per Minute Standard Deviation 0.7	-1.7 Breaths per Minute Standard Deviation 6.0	-2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 10 Day 1	-0.2 Breaths per Minute Standard Deviation 1.6	-0.5 Breaths per Minute Standard Deviation 2.1	-0.3 Breaths per Minute Standard Deviation 5.5	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 11 Day 1	-0.8 Breaths per Minute Standard Deviation 1.0	1.0 Breaths per Minute Standard Deviation 0	-0.5 Breaths per Minute Standard Deviation 0.7	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 12 Day 1	-0.4 Breaths per Minute Standard Deviation 1.5	1.0 Breaths per Minute Standard Deviation 0	1.5 Breaths per Minute Standard Deviation 0.7	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 13 Day 1	-1.4 Breaths per Minute Standard Deviation 2.8	1.0 Breaths per Minute Standard Deviation 0	-1.0 Breaths per Minute Standard Deviation 0	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 14 Day 1	0.8 Breaths per Minute Standard Deviation 2.3	1.0 Breaths per Minute Standard Deviation 0	1.0 Breaths per Minute Standard Deviation 0	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 15 Day 1	0.0 Breaths per Minute Standard Deviation 1.4	1.0 Breaths per Minute Standard Deviation 0	-1.0 Breaths per Minute Standard Deviation 0	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 16 Day 1	-0.3 Breaths per Minute Standard Deviation 1.3	1.0 Breaths per Minute Standard Deviation 0	-2.0 Breaths per Minute Standard Deviation 0	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 17 Day 1	1.3 Breaths per Minute Standard Deviation 2.3	1.0 Breaths per Minute Standard Deviation 0	-2.0 Breaths per Minute Standard Deviation 0	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 18 Day 1	1.3 Breaths per Minute Standard Deviation 2.3	—	-1.0 Breaths per Minute Standard Deviation 0	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 19 Day 1	1.5 Breaths per Minute Standard Deviation 2.1	—	-3.0 Breaths per Minute Standard Deviation 0	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 20 Day 1	2.0 Breaths per Minute Standard Deviation 2.8	—	-3.0 Breaths per Minute Standard Deviation 0	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 21 Day 1	2.0 Breaths per Minute Standard Deviation 0	—	—	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 22 Day 1	0.0 Breaths per Minute Standard Deviation 0	—	—	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 23 Day 1	—	—	—	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Final visit	-0.3 Breaths per Minute Standard Deviation 1.5	-1.2 Breaths per Minute Standard Deviation 1.5	-1.8 Breaths per Minute Standard Deviation 1.8	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Baseline	17.4 Breaths per Minute Standard Deviation 2.0	17.4 Breaths per Minute Standard Deviation 1.9	18.2 Breaths per Minute Standard Deviation 2.6	16.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 1 Day 15	-0.3 Breaths per Minute Standard Deviation 1.0	-0.2 Breaths per Minute Standard Deviation 1.8	-0.2 Breaths per Minute Standard Deviation 1.8	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 1 Day 22	-0.5 Breaths per Minute Standard Deviation 0.8	0.2 Breaths per Minute Standard Deviation 0.4	-0.5 Breaths per Minute Standard Deviation 2.2	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 2 Day 1	-0.3 Breaths per Minute Standard Deviation 1.5	-0.3 Breaths per Minute Standard Deviation 1.7	-0.4 Breaths per Minute Standard Deviation 1.7	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 2 Day 15	-0.2 Breaths per Minute Standard Deviation 1.0	0.0 Breaths per Minute Standard Deviation 0.8	-1.2 Breaths per Minute Standard Deviation 1.8	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 3 Day 1	-0.7 Breaths per Minute Standard Deviation 1.3	-1.5 Breaths per Minute Standard Deviation 3.1	-1.8 Breaths per Minute Standard Deviation 1.8	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 3 Day 15	-0.7 Breaths per Minute Standard Deviation 1.3	0.0 Breaths per Minute Standard Deviation 1.0	-1.0 Breaths per Minute Standard Deviation 1.0	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 4 Day 1	-0.3 Breaths per Minute Standard Deviation 1.3	-3.3 Breaths per Minute Standard Deviation 4.2	-1.0 Breaths per Minute Standard Deviation 1.0	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 5 Day 1	-0.4 Breaths per Minute Standard Deviation 1.9	-0.3 Breaths per Minute Standard Deviation 0.6	1.0 Breaths per Minute Standard Deviation 2.2	0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 6 Day 1	-0.5 Breaths per Minute Standard Deviation 1.3	-0.5 Breaths per Minute Standard Deviation 1.9	-0.6 Breaths per Minute Standard Deviation 1.3	2.0 Breaths per Minute Standard Deviation 0
Change From Baseline in Respiratory Rate Cycle 7 Day 1	-0.2 Breaths per Minute Standard Deviation 1.7	0 Breaths per Minute Standard Deviation 0	-2.3 Breaths per Minute Standard Deviation 1.5	2.0 Breaths per Minute Standard Deviation 0

Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Systolic Blood Pressure Baseline	129.3 Millimeters of mercury (mmHg) Standard Deviation 11.5	132.0 Millimeters of mercury (mmHg) Standard Deviation 17.2	122.3 Millimeters of mercury (mmHg) Standard Deviation 16.9	106.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 1, Day 15	4.4 Millimeters of mercury (mmHg) Standard Deviation 9.9	3.6 Millimeters of mercury (mmHg) Standard Deviation 13.6	3.8 Millimeters of mercury (mmHg) Standard Deviation 15.1	5.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 1, Days 22	3.3 Millimeters of mercury (mmHg) Standard Deviation 9.4	-5.6 Millimeters of mercury (mmHg) Standard Deviation 11.8	4.8 Millimeters of mercury (mmHg) Standard Deviation 10.1	-5.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 2, Day 1	3.0 Millimeters of mercury (mmHg) Standard Deviation 10.3	2.8 Millimeters of mercury (mmHg) Standard Deviation 8.4	-4.3 Millimeters of mercury (mmHg) Standard Deviation 7.9	10.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 2 , Day 15	5.2 Millimeters of mercury (mmHg) Standard Deviation 9.8	-2.0 Millimeters of mercury (mmHg) Standard Deviation 13.6	-7.2 Millimeters of mercury (mmHg) Standard Deviation 9.6	30.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 3, Day 1	5.5 Millimeters of mercury (mmHg) Standard Deviation 10.8	-3.0 Millimeters of mercury (mmHg) Standard Deviation 9.8	7.3 Millimeters of mercury (mmHg) Standard Deviation 18.3	0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 3, Day 15	1.2 Millimeters of mercury (mmHg) Standard Deviation 11.2	-3.5 Millimeters of mercury (mmHg) Standard Deviation 14.2	-3.8 Millimeters of mercury (mmHg) Standard Deviation 16.7	6.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 4, Day 1	2.2 Millimeters of mercury (mmHg) Standard Deviation 9.1	-7.3 Millimeters of mercury (mmHg) Standard Deviation 9.3	9.8 Millimeters of mercury (mmHg) Standard Deviation 8.1	13.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 5, Day 1	4.2 Millimeters of mercury (mmHg) Standard Deviation 10.5	-2.5 Millimeters of mercury (mmHg) Standard Deviation 6.8	3.3 Millimeters of mercury (mmHg) Standard Deviation 6.9	16.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 6 Day 1	11.2 Millimeters of mercury (mmHg) Standard Deviation 13.0	2.5 Millimeters of mercury (mmHg) Standard Deviation 9.7	8.6 Millimeters of mercury (mmHg) Standard Deviation 10.8	8.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 7 Day 1	4.7 Millimeters of mercury (mmHg) Standard Deviation 4.2	-4.0 Millimeters of mercury (mmHg) Standard Deviation 15.6	10.0 Millimeters of mercury (mmHg) Standard Deviation 5.0	29.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 8 Day 1	8.8 Millimeters of mercury (mmHg) Standard Deviation 9.0	5.0 Millimeters of mercury (mmHg) Standard Deviation 7.1	14.0 Millimeters of mercury (mmHg) Standard Deviation 18.8	9.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 9 Day 1	12.6 Millimeters of mercury (mmHg) Standard Deviation 8.3	3.0 Millimeters of mercury (mmHg) Standard Deviation 9.9	-4.3 Millimeters of mercury (mmHg) Standard Deviation 4.9	26.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 10 Day 1	11.8 Millimeters of mercury (mmHg) Standard Deviation 9.9	-3.0 Millimeters of mercury (mmHg) Standard Deviation 2.8	11.0 Millimeters of mercury (mmHg) Standard Deviation 13.2	30.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 11 Day 1	8.5 Millimeters of mercury (mmHg) Standard Deviation 12.3	14.0 Millimeters of mercury (mmHg) Standard Deviation 0	11.0 Millimeters of mercury (mmHg) Standard Deviation 12.7	34.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 12 Day 1	10.8 Millimeters of mercury (mmHg) Standard Deviation 11.5	-8.0 Millimeters of mercury (mmHg) Standard Deviation 0	6.5 Millimeters of mercury (mmHg) Standard Deviation 3.5	6.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 13 Day 1	13.4 Millimeters of mercury (mmHg) Standard Deviation 5.1	-8.0 Millimeters of mercury (mmHg) Standard Deviation 0	8.0 Millimeters of mercury (mmHg) Standard Deviation 0	14.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 14 Day 1	4.4 Millimeters of mercury (mmHg) Standard Deviation 14.7	18.0 Millimeters of mercury (mmHg) Standard Deviation 0	3.0 Millimeters of mercury (mmHg) Standard Deviation 0	14.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 15 Day 1	13.6 Millimeters of mercury (mmHg) Standard Deviation 7.5	14.0 Millimeters of mercury (mmHg) Standard Deviation 0	4.0 Millimeters of mercury (mmHg) Standard Deviation 0	5.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 16 Day 1	7.5 Millimeters of mercury (mmHg) Standard Deviation 8.6	8.0 Millimeters of mercury (mmHg) Standard Deviation 0	9.0 Millimeters of mercury (mmHg) Standard Deviation 0	4.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 17 Day 1	9.3 Millimeters of mercury (mmHg) Standard Deviation 5.8	24.0 Millimeters of mercury (mmHg) Standard Deviation 0	7.0 Millimeters of mercury (mmHg) Standard Deviation 0	6.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 18 Day 1	5.7 Millimeters of mercury (mmHg) Standard Deviation 4.2	—	9.0 Millimeters of mercury (mmHg) Standard Deviation 0	13.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 19 Day 1	2.5 Millimeters of mercury (mmHg) Standard Deviation 3.5	—	9.0 Millimeters of mercury (mmHg) Standard Deviation 0	13.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 20 Day 1	11.5 Millimeters of mercury (mmHg) Standard Deviation 9.2	—	9.0 Millimeters of mercury (mmHg) Standard Deviation 0	13.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 21 Day 1	-18.0 Millimeters of mercury (mmHg) Standard Deviation 0	—	—	7.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 22 Day 1	24.0 Millimeters of mercury (mmHg) Standard Deviation 0	—	—	6.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Cycle 23 Day 1	—	—	—	11.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Systolic Blood Pressure Final Visit	1.3 Millimeters of mercury (mmHg) Standard Deviation 9.7	7.6 Millimeters of mercury (mmHg) Standard Deviation 16.2	12.8 Millimeters of mercury (mmHg) Standard Deviation 23.9	19.0 Millimeters of mercury (mmHg) Standard Deviation 0

Measure	Ruxolitinib-Naïve Participants With Splenomegaly n=15 Participants 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).	Ruxolitinib-Naïve Participants Without Splenomegaly n=5 Participants 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).	Total Ruxolitinib-Naïve Participants n=6 Participants 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).	Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly n=1 Participants 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).
Change From Baseline in Diastolic Blood Pressure Cycle 5, Day 1	1.7 Millimeters of mercury (mmHg) Standard Deviation 6.1	5.0 Millimeters of mercury (mmHg) Standard Deviation 5.8	-5.0 Millimeters of mercury (mmHg) Standard Deviation 4.5	1.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 6, Day 1	5.9 Millimeters of mercury (mmHg) Standard Deviation 4.5	3.3 Millimeters of mercury (mmHg) Standard Deviation 11.1	-2.0 Millimeters of mercury (mmHg) Standard Deviation 9.5	12.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 7, Day 1	2.9 Millimeters of mercury (mmHg) Standard Deviation 4.8	4.5 Millimeters of mercury (mmHg) Standard Deviation 13.4	-5.3 Millimeters of mercury (mmHg) Standard Deviation 9.0	30.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Baseline	76.3 Millimeters of mercury (mmHg) Standard Deviation 7.8	73.2 Millimeters of mercury (mmHg) Standard Deviation 5.2	72.3 Millimeters of mercury (mmHg) Standard Deviation 9.0	65.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle1, Day 15	5.1 Millimeters of mercury (mmHg) Standard Deviation 8.7	10.0 Millimeters of mercury (mmHg) Standard Deviation 8.7	-1.8 Millimeters of mercury (mmHg) Standard Deviation 3.4	0.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 1, Day 22	3.6 Millimeters of mercury (mmHg) Standard Deviation 6.1	2.4 Millimeters of mercury (mmHg) Standard Deviation 3.2	-2.2 Millimeters of mercury (mmHg) Standard Deviation 5.8	-1.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 2, Day 1	6.1 Millimeters of mercury (mmHg) Standard Deviation 8.3	3.0 Millimeters of mercury (mmHg) Standard Deviation 2.9	-0.2 Millimeters of mercury (mmHg) Standard Deviation 9.3	3.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 2, Day 15	4.1 Millimeters of mercury (mmHg) Standard Deviation 6.3	2.5 Millimeters of mercury (mmHg) Standard Deviation 9.7	-5.5 Millimeters of mercury (mmHg) Standard Deviation 3.4	16.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 3 Day 1	6.2 Millimeters of mercury (mmHg) Standard Deviation 8.1	5.8 Millimeters of mercury (mmHg) Standard Deviation 10.0	-4.0 Millimeters of mercury (mmHg) Standard Deviation 12.4	5.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 3, Day 15	1.8 Millimeters of mercury (mmHg) Standard Deviation 10.5	2.0 Millimeters of mercury (mmHg) Standard Deviation 10.1	-7.5 Millimeters of mercury (mmHg) Standard Deviation 7.0	8.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 4, Day 1	5.5 Millimeters of mercury (mmHg) Standard Deviation 5.7	2.7 Millimeters of mercury (mmHg) Standard Deviation 6.8	-0.4 Millimeters of mercury (mmHg) Standard Deviation 5.0	1.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 8, Day 1	7.8 Millimeters of mercury (mmHg) Standard Deviation 5.4	5.0 Millimeters of mercury (mmHg) Standard Deviation 7.1	0.5 Millimeters of mercury (mmHg) Standard Deviation 12.3	10.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 9, Day 1	4.1 Millimeters of mercury (mmHg) Standard Deviation 8.4	4.0 Millimeters of mercury (mmHg) Standard Deviation 5.7	-2.7 Millimeters of mercury (mmHg) Standard Deviation 1.5	4.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 10, Day 1	3.7 Millimeters of mercury (mmHg) Standard Deviation 5.9	5.0 Millimeters of mercury (mmHg) Standard Deviation 0	-2.3 Millimeters of mercury (mmHg) Standard Deviation 10.1	3.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 11, Day 1	9.7 Millimeters of mercury (mmHg) Standard Deviation 14.1	10.0 Millimeters of mercury (mmHg) Standard Deviation 0	1.0 Millimeters of mercury (mmHg) Standard Deviation 7.1	24.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 12, Day 1	9.8 Millimeters of mercury (mmHg) Standard Deviation 8.6	6.0 Millimeters of mercury (mmHg) Standard Deviation 0	2.0 Millimeters of mercury (mmHg) Standard Deviation 4.2	8.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 13, Day 1	9.0 Millimeters of mercury (mmHg) Standard Deviation 7.6	4.0 Millimeters of mercury (mmHg) Standard Deviation 0	2.0 Millimeters of mercury (mmHg) Standard Deviation 0	10.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 14, Day 1	5.6 Millimeters of mercury (mmHg) Standard Deviation 5.1	19.0 Millimeters of mercury (mmHg) Standard Deviation 0	-9.0 Millimeters of mercury (mmHg) Standard Deviation 0	11.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 15, Day 1	7.0 Millimeters of mercury (mmHg) Standard Deviation 8.0	10.0 Millimeters of mercury (mmHg) Standard Deviation 0	-2.0 Millimeters of mercury (mmHg) Standard Deviation 0	7.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 16, Day 1	9.8 Millimeters of mercury (mmHg) Standard Deviation 7.8	11.0 Millimeters of mercury (mmHg) Standard Deviation 0	7.0 Millimeters of mercury (mmHg) Standard Deviation 0	6.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 17, Day 1	11.3 Millimeters of mercury (mmHg) Standard Deviation 3.5	11.0 Millimeters of mercury (mmHg) Standard Deviation 0	3.0 Millimeters of mercury (mmHg) Standard Deviation 0	7.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 18, Day 1	5.0 Millimeters of mercury (mmHg) Standard Deviation 1.7	—	-2.0 Millimeters of mercury (mmHg) Standard Deviation 0	3.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 19, Day 1	4.0 Millimeters of mercury (mmHg) Standard Deviation 5.7	—	5.0 Millimeters of mercury (mmHg) Standard Deviation 0	8.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 20, Day 1	12.5 Millimeters of mercury (mmHg) Standard Deviation 3.5	—	-1.0 Millimeters of mercury (mmHg) Standard Deviation 0	2.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 21, Day 1	-3.0 Millimeters of mercury (mmHg) Standard Deviation 0	—	—	7.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 22, Day 1	22.0 Millimeters of mercury (mmHg) Standard Deviation 0	—	—	8.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Cycle 23, Day 1	—	—	—	7.0 Millimeters of mercury (mmHg) Standard Deviation 0
Change From Baseline in Diastolic Blood Pressure Final visit	5.8 Millimeters of mercury (mmHg) Standard Deviation 9.0	3.8 Millimeters of mercury (mmHg) Standard Deviation 14.0	-2.0 Millimeters of mercury (mmHg) Standard Deviation 12.6	11.0 Millimeters of mercury (mmHg) Standard Deviation 0