Trial Outcomes & Findings for Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations. (NCT NCT02598297)

Last Updated: 2019-08-16

Results Overview

Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression: * Progressive splenomegaly * Circulating peripheral blast counts \> 10% * Leukemic transformation * Hb \< 10g/dl with absolute decrease of at least 3 g/dl from baseline * White blood cell (WBC) counts \> 25 x 103/ μL * MF-7 score ≥ 30 * Death from any cause

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

From randomization till disease progression (estimated to be assessed up 48 months)

Results posted on

2019-08-16

Participant Flow

Approximately 320 male or female adults (age 18 or over) with a confirmed diagnosis of MF were planned to be enrolled. The target population was not met due to early study termination. A total of 49 subjects were enrolled in the study, 25 in the ruxolitinib arm and 24 in the placebo arm.

Participant milestones

Participant milestones
Measure	Ruxolitinib (INC424) Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo Two tablets of 5mg placebo were administered orally twice per day
Overall Study STARTED	25	24
Overall Study Not Treted Wit Study Drug	1	0
Overall Study Subjects Followed for Survival	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Ruxolitinib (INC424) Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo Two tablets of 5mg placebo were administered orally twice per day
Overall Study Study terminated by Sponsor	21	23
Overall Study Adverse Event	1	1
Overall Study Physician Decision	1	0
Overall Study Subject/guardian decision	1	0
Overall Study Followed for survival	1	0

Baseline Characteristics

The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib (INC424) n=25 Participants Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 Participants Two tablets of 5mg placebo were administered orally twice per day	Total n=49 Participants Total of all reporting groups
Age, Continuous	59.0 Years STANDARD_DEVIATION 14.23 • n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	67.4 Years STANDARD_DEVIATION 7.72 • n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	63.1 Years STANDARD_DEVIATION 12.17 • n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Sex: Female, Male Female	12 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	7 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	19 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Sex: Female, Male Male	13 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	17 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	30 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Race/Ethnicity, Customized Caucasian	19 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	23 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	42 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	1 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	5 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Race/Ethnicity, Customized Other	1 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	0 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	1 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	0 Participants n=7 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.	1 Participants n=5 Participants • The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.

PRIMARY outcome

Timeframe: From randomization till disease progression (estimated to be assessed up 48 months)

Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that the primary endpoint of PFS and any other time to event endpoint would not be derived.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization till progression (estimated to be assessed up to 48 months)

TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline and assessed on 12 week intervals until end of treatment (EOT)

Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.

Change in spleen volume (by MRI/CT) from baseline

Outcome measures

Outcome measures
Measure	Ruxolitinib (INC424) n=25 Participants Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 Participants Two tablets of 5mg placebo were administered orally twice per day
Percentage Change in Spleen Volume From Baseline Week 36	-18.4 Percentage change from baseline Standard Deviation 31.62	32.5 Percentage change from baseline Standard Deviation 18.81
Percentage Change in Spleen Volume From Baseline Week 12	-10.8 Percentage change from baseline Standard Deviation 24.45	9.1 Percentage change from baseline Standard Deviation 12.34
Percentage Change in Spleen Volume From Baseline Week 24	-17.8 Percentage change from baseline Standard Deviation 18.83	17.6 Percentage change from baseline Standard Deviation 17.78
Percentage Change in Spleen Volume From Baseline Week 48	-23.5 Percentage change from baseline Standard Deviation 10.57	—
Percentage Change in Spleen Volume From Baseline End of Treatment (EOT)	-11.6 Percentage change from baseline Standard Deviation 8.08	18.1 Percentage change from baseline Standard Deviation 18.58

SECONDARY outcome

Timeframe: From Baseline and assessed every 4 weeks until end of treatment

Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.

Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline and assessed every 4 weeks until end of treatment

Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. Only the categories with non-zero counts are presented with these results. Only subjects with baseline score and at least one non-missing post-baseline score during the treatment period 1 were included. % is based on all these evaluable subjects.

EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg "I have no problems walking" to "I am unable to walk"), except for the following overall health check, where 100 is the best of health, and 0 is the worst health.

Outcome measures

Outcome measures
Measure	Ruxolitinib (INC424) n=25 Participants Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 Participants Two tablets of 5mg placebo were administered orally twice per day
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - EOT: No problem	8 Participants	10 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- Baseline: No problem	17 Participants	18 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- Baseline: Slight problems	4 Participants	5 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- Baseline: Moderate problems	1 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- Baseline: Extreme problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 4:No prob.	17 Participants	14 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 4: Slight problems	4 Participants	7 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 4: Moderate problems	1 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 8: No problem	17 Participants	15 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 8: Slight problems	3 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 8: Moderate problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 12: No problem	15 Participants	12 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 12: Slight problems	4 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 12: Moderate problems	0 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 16: No problem	12 Participants	10 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 16: Slight problems	2 Participants	7 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 16: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 20: No problem	12 Participants	5 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 20: Slight problems	2 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 24: No problem	12 Participants	5 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 24: Slight problems	1 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 24: Moderate problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 32: No problem	8 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 32: Slight problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 32: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 40: No problem	5 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 40: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 48: No problem	2 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - Week 48: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - EOT: No problem	11 Participants	12 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - EOT: Slight problems	4 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility - EOT: Moderate problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- 30 day safety FU: No problem	2 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Mobility- 30 day safety FU: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Baseline: No problem	23 Participants	22 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Baseline: Slight problems	0 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 4: No problem	21 Participants	20 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 4: Slight problems	0 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 4: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 8: No problem	19 Participants	21 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 8: Slight problems	1 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 12: No problem	17 Participants	19 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 12: Slight problems	1 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 12: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 16: No problem	15 Participants	16 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 16: Slight problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 20: No problem	14 Participants	11 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 24: No problem	12 Participants	9 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 24: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 32: No problem	8 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 32: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 40: No problem	5 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 40: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - Week 48: No problem	3 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - EOT: No problem	14 Participants	15 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - EOT: Slight problems	1 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Self-care - 30 day Safety FU: No problem	3 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities -Baseline: No problem	18 Participants	21 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities -Baseline: Slight problems	4 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Baseline: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 4: No problem	11 Participants	15 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 4: No problem	20 Participants	18 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 4: Slight problems	1 Participants	4 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 4: Moderate problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 4: Severe problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 8: No problem	20 Participants	18 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 8: Slight problems	0 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 8: Moderate problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 12: No problem	16 Participants	16 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 12: Slight problems	3 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 12: Moderate problems	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 16: No problem	13 Participants	14 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 16: Slight problems	2 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 20: No problem	13 Participants	9 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 4: Slight problems	10 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 20: Slight problems	1 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 24: No problem	12 Participants	9 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 24: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 32: No problem	8 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 32: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 40: No problem	5 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 40: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - Week 48: No problem	3 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - EOT: No problem	12 Participants	13 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities -EOT: Slight problems	3 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - 30 day Safety FU: No problem	2 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Usual activities - 30 say Safety FU: Slight probs	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Baseline: No problem	13 Participants	11 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Baseline: Slight problems	8 Participants	12 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Baseline: Moderate problems	2 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 4: Moderate problems	1 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 8: No problem	14 Participants	13 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 8: Slight problems	5 Participants	7 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 8: Moderate problems	1 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 12: No problem	12 Participants	10 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 12: Slight problems	7 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 12: Moderate problems	0 Participants	4 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - Week 16: No problem	9 Participants	11 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK16: Slight problems	6 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK16: Moderate problems	0 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK20: No problem	8 Participants	8 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK20: Slight problems	6 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK24: No problem	9 Participants	7 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK24: Slight problems	4 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK32: No problem	7 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK32: Slight problems	2 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK40: No problem	4 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK40: Slight problems	2 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - WK48: No problem	3 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - EOT: Slight problems	7 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - EOT: Moderate problems	0 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - 30 day Safety FU: No problem	1 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - 30 day safety FU: Slight probs	2 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Pain/Discomfort - 30 day Safety FU: Moderate probs	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - Baseline: No problem	14 Participants	18 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - Baseline: Slight problems	6 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - Baseline: Moderate problems	3 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK4: No problem	13 Participants	15 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK4: Slight problems	7 Participants	6 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK4: Moderate problems	2 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK8: No problem	11 Participants	16 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK8: Slight problems	8 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK8: Moderate problems	1 Participants	4 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK12: No problem	8 Participants	13 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK12: Slight problems	10 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression -WK12: Moderate problems	1 Participants	4 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK16: No problem	10 Participants	10 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK16: Slight problems	5 Participants	5 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK16: Moderate problems	0 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression -WK20: No problem	10 Participants	8 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK20: Slight problems	4 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK24: No problem	11 Participants	7 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK24: Slight problems	2 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK32: No problem	7 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK32: Slight problems	2 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK40: No problem	5 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK40: Slight problems	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - WK48: No problem	3 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - EOT: No problem	11 Participants	12 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - EOT: Slight probs	4 Participants	3 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - EOT: Moderate probs	0 Participants	1 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression - 30 day Safety FU: No probs	2 Participants	2 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression-30 day Safety FU: Slight probs	1 Participants	0 Participants
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D Anxiety/Depression-30 day Safety FU: Severe probs	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months).

To evaluate the effect of ruxolitinib on overall survival

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12, Wk 48

Ruxolitinib (INC424)

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Ruxolitinib Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ruxolitinib (INC424) n=24 participants at risk Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 participants at risk Two tablets of 5mg placebo were administered orally twice per day
Injury, poisoning and procedural complications Tendon rupture	4.2% 1/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	4.2% 1/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	4.2% 1/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.

Other adverse events

Other adverse events
Measure	Ruxolitinib (INC424) n=24 participants at risk Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 participants at risk Two tablets of 5mg placebo were administered orally twice per day
Blood and lymphatic system disorders Anaemia	29.2% 7/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	25.0% 6/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	8.3% 2/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
General disorders Fatigue	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	16.7% 4/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
General disorders Pyrexia	8.3% 2/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Infections and infestations Nasopharyngitis	16.7% 4/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Infections and infestations Respiratory tract infection	8.3% 2/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Infections and infestations Upper respiratory tract infection	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Infections and infestations Urinary tract infection	8.3% 2/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Skin and subcutaneous tissue disorders Night sweats	4.2% 1/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	8.3% 2/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
Vascular disorders Hypertension	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.	12.5% 3/24 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks. One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ruxolitinib (INC424) n=25 Participants Two tablets of ruxolitinib 5 mg were administered orally twice per day	Ruxolitinib Placebo n=24 Participants Two tablets of 5mg placebo were administered orally twice per day
Percentage Change in Symptoms From Baseline Using MF-7 Tiredness: Baseline (BL)	1.8 Percentage change in scores Standard Deviation 1.45	1.5 Percentage change in scores Standard Deviation 1.53
Percentage Change in Symptoms From Baseline Using MF-7 Tiredness: change from baseline @ W12	0.1 Percentage change in scores Standard Deviation 1.47	0.4 Percentage change in scores Standard Deviation 1.27
Percentage Change in Symptoms From Baseline Using MF-7 Total Score derived (TSD): Baseline (BL)	6.6 Percentage change in scores Standard Deviation 5.17	5.9 Percentage change in scores Standard Deviation 5.56
Percentage Change in Symptoms From Baseline Using MF-7 TSD change from baseline @ W12	-0.3 Percentage change in scores Standard Deviation 4.45	0.5 Percentage change in scores Standard Deviation 6.08
Percentage Change in Symptoms From Baseline Using MF-7 TSD change from baseline @ W24	0.5 Percentage change in scores Standard Deviation 3.71	-0.8 Percentage change in scores Standard Deviation 6.44
Percentage Change in Symptoms From Baseline Using MF-7 TSD change from baseline @ W48	-0.3 Percentage change in scores Standard Deviation 3.06	—
Percentage Change in Symptoms From Baseline Using MF-7 TSD change from BL @ EOT	1.1 Percentage change in scores Standard Deviation 4.40	3.3 Percentage change in scores Standard Deviation 9.53
Percentage Change in Symptoms From Baseline Using MF-7 Tiredness: change from baseline @ W24	-0.1 Percentage change in scores Standard Deviation 0.76	1.1 Percentage change in scores Standard Deviation 2.52
Percentage Change in Symptoms From Baseline Using MF-7 Tiredness: change from baseline @ W48	-0.3 Percentage change in scores Standard Deviation 0.58	—
Percentage Change in Symptoms From Baseline Using MF-7 Tiredness change from BL @ EOT	0.8 Percentage change in scores Standard Deviation 1.32	1.1 Percentage change in scores Standard Deviation 2.28
Percentage Change in Symptoms From Baseline Using MF-7 Filling up quickly when you eat (FUQWYE):BL	1.0 Percentage change in scores Standard Deviation 1.41	0.8 Percentage change in scores Standard Deviation 1.27
Percentage Change in Symptoms From Baseline Using MF-7 FUQWYE: change from BL @W12	0.1 Percentage change in scores Standard Deviation 1.49	-0.1 Percentage change in scores Standard Deviation 2.09
Percentage Change in Symptoms From Baseline Using MF-7 FUQWYE: change from BL @W24	-0.2 Percentage change in scores Standard Deviation 0.99	0.1 Percentage change in scores Standard Deviation 1.17
Percentage Change in Symptoms From Baseline Using MF-7 FUQWYE: change from BL @W48	0.7 Percentage change in scores Standard Deviation 1.15	—
Percentage Change in Symptoms From Baseline Using MF-7 FUQWYE: change from BL @ EOT	0.2 Percentage change in scores Standard Deviation 1.08	0.3 Percentage change in scores Standard Deviation 2.29
Percentage Change in Symptoms From Baseline Using MF-7 Abdominal discomfort (AD): BL	0.7 Percentage change in scores Standard Deviation 1.43	0.6 Percentage change in scores Standard Deviation 1.10
Percentage Change in Symptoms From Baseline Using MF-7 Abdominal discomfort change from BL @W12	-0.1 Percentage change in scores Standard Deviation 1.66	-0.1 Percentage change in scores Standard Deviation 0.85
Percentage Change in Symptoms From Baseline Using MF-7 Abdominal discomfort change from BL @W24	0.0 Percentage change in scores Standard Deviation 1.15	-0.3 Percentage change in scores Standard Deviation 0.71
Percentage Change in Symptoms From Baseline Using MF-7 Abdominal discomfort change from BL @W48	0.0 Percentage change in scores Standard Deviation 0.00	—
Percentage Change in Symptoms From Baseline Using MF-7 AD: change from BL @ EOT	0.1 Percentage change in scores Standard Deviation 0.92	0.3 Percentage change in scores Standard Deviation 1.40
Percentage Change in Symptoms From Baseline Using MF-7 Night sweat (NS): Baseline (BL)	0.7 Percentage change in scores Standard Deviation 1.07	1.1 Percentage change in scores Standard Deviation 1.45
Percentage Change in Symptoms From Baseline Using MF-7 Night sweat change from BL @W12	-0.1 Percentage change in scores Standard Deviation 0.71	-0.3 Percentage change in scores Standard Deviation 1.29
Percentage Change in Symptoms From Baseline Using MF-7 Night sweat change from BL @W24	0.5 Percentage change in scores Standard Deviation 1.45	-0.7 Percentage change in scores Standard Deviation 1.41
Percentage Change in Symptoms From Baseline Using MF-7 Night sweat change from BL @W48	-0.3 Percentage change in scores Standard Deviation 0.58	—
Percentage Change in Symptoms From Baseline Using MF-7 Night Sweat: change from BL @ EOT	0.0 Percentage change in scores Standard Deviation 0.85	0.3 Percentage change in scores Standard Deviation 2.12
Percentage Change in Symptoms From Baseline Using MF-7 Itching (Pruritus):BL	0.9 Percentage change in scores Standard Deviation 1.42	0.6 Percentage change in scores Standard Deviation 0.93
Percentage Change in Symptoms From Baseline Using MF-7 Itching (Pruritus): change from BL @W12	-0.3 Percentage change in scores Standard Deviation 0.67	0.1 Percentage change in scores Standard Deviation 1.45
Percentage Change in Symptoms From Baseline Using MF-7 Itching (Pruritus): change from BL @W24	0.4 Percentage change in scores Standard Deviation 0.77	-0.3 Percentage change in scores Standard Deviation 1.22
Percentage Change in Symptoms From Baseline Using MF-7 Itching (Pruritus): change from BL @W48	-1.0 Percentage change in scores Standard Deviation 1.73	—
Percentage Change in Symptoms From Baseline Using MF-7 Itching: change from BL @ EOT	0.1 Percentage change in scores Standard Deviation 1.03	0.4 Percentage change in scores Standard Deviation 1.75
Percentage Change in Symptoms From Baseline Using MF-7 Bone Pain: BL	0.9 Percentage change in scores Standard Deviation 1.35	0.9 Percentage change in scores Standard Deviation 1.33
Percentage Change in Symptoms From Baseline Using MF-7 Bone Pain: change from BL @W12	-0.4 Percentage change in scores Standard Deviation 1.01	0.3 Percentage change in scores Standard Deviation 1.56
Percentage Change in Symptoms From Baseline Using MF-7 Bone Pain: change from BL @W24	-0.2 Percentage change in scores Standard Deviation 1.17	-0.8 Percentage change in scores Standard Deviation 1.79
Percentage Change in Symptoms From Baseline Using MF-7 Bone Pain: change from BL @W48	0.7 Percentage change in scores Standard Deviation 1.15	—
Percentage Change in Symptoms From Baseline Using MF-7 Bone Pain: change from BL @ EOT	0.1 Percentage change in scores Standard Deviation 0.96	0.6 Percentage change in scores Standard Deviation 1.50
Percentage Change in Symptoms From Baseline Using MF-7 Pain under ribs on left side (PUROLS): BL	0.7 Percentage change in scores Standard Deviation 1.18	0.4 Percentage change in scores Standard Deviation 0.82
Percentage Change in Symptoms From Baseline Using MF-7 PUROLS: change from BL @W12	0.4 Percentage change in scores Standard Deviation 1.01	0.1 Percentage change in scores Standard Deviation 0.76
Percentage Change in Symptoms From Baseline Using MF-7 PUROLS: change from BL @W24	0.0 Percentage change in scores Standard Deviation 0.41	0.1 Percentage change in scores Standard Deviation 1.17
Percentage Change in Symptoms From Baseline Using MF-7 PUROLS: change from BL @W48	0.0 Percentage change in scores Standard Deviation 0.00	—
Percentage Change in Symptoms From Baseline Using MF-7 PUROLS: change from BL @ EOT	-0.2 Percentage change in scores Standard Deviation 0.68	0.3 Percentage change in scores Standard Deviation 1.00