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    Clinical Trial Results:
    Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes

    Summary
    EudraCT number
    		 2012-002318-37
    Trial protocol
    		 GB   BE   IT   ES   IE  
    Global end of trial date
    24 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2017
    First version publication date
    21 Jul 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB18424-357
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01632904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cut-Off, Wilmington, United States, 19803
    Public contact
    Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com
    Scientific contact
    Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    27 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the RELIEF study was to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieved a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study was also designed to demonstrate that these responses are durable with continued treatment.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 56
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Italy: 18
    Worldwide total number of subjects
    110
    EEA total number of subjects
    54
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    51
    From 65 to 84 years
    57
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 54 study centers including 1 in Belgium, 6 in Germany, 3 in Italy, 3 in Spain, 4 in UK (total 17 ex-US), and 37 in United States.

    Pre-assignment
    Screening details
    		 Subjects with polycythemia vera (PV) who received hydroxyurea (HU) for at least 12 weeks and had been receiving a stable dose for 4 weeks before screening and still had symptoms related to PV were enrolled. Subjects were randomized (1:1) to 1 of 2 treatment groups: • Ruxolitinib and HU-placebo • HU and ruxolitinib-placebo

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ruxolitinib
    Arm description
    		 Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy. HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.

    Investigational medicinal product name
    HU-placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.

    Arm title
    		 Hydroxyurea
    Arm description
    		 Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria. Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydroxyurea (HU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.

    Investigational medicinal product name
    Ruxolitinib-placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.

    Number of subjects in period 1
    		Ruxolitinib Hydroxyurea
    Started
    54
    56
    Completed
    47
    50
    Not completed
    7
    6
         Physician decision
    -
    1
         Adverse event, non-fatal
    4
    1
         Subject decision
    3
    2
         Reason for discontinuation not available
    -
    1
         Disease Progression
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy. HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.

    Reporting group title
    Hydroxyurea
    Reporting group description
    		 Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria. Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.

    Reporting group values
    		 Ruxolitinib Hydroxyurea Total
    Number of subjects
    		 54 56 110
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 28 23 51
        From 65-84 years
    		 25 32 57
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ( 11.68 ) 64.2 ( 12.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 22 52
        Male
    		 24 34 58

    End points

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    End points reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy. HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.

    Reporting group title
    Hydroxyurea
    Reporting group description
    		 Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria. Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.

    Primary: Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary

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    End point title
    		 Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary
    End point description
    Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 Ruxolitinib Hydroxyurea
    Number of subjects analysed
    53 [1]
    54 [2]
    Units: Percentage of participants
        number (not applicable)
    43.4
    29.6
    Notes
    [1] - Intent-to-Treat (ITT); all subjects randomized in the study.
    [2] - Intent-to-Treat (ITT); all subjects randomized in the study.
    Statistical analysis title
    		 Improvement From Baseline in TSS-C
    Comparison groups
    Ruxolitinib v Hydroxyurea
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 4.04

    Secondary: Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16

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    End point title
    		 Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16
    End point description
    The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 Ruxolitinib Hydroxyurea
    Number of subjects analysed
    53 [3]
    54 [4]
    Units: Percentage of participants
    number (not applicable)
        Tiredness (n= 50, 53)
    40
    26.4
        Itching (n= 48, 50)
    54.2
    32
        Muscle aches (n= 47, 49)
    38.3
    30.6
        Night sweats (n= 42, 48)
    47.6
    41.7
        Sweats while awake (n= 42, 46)
    54.8
    34.8
    Notes
    [3] - Intent-to-Treat (ITT); all subjects randomized in the study.
    [4] - Intent-to-Treat (ITT); all subjects randomized in the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The duration of the study up to Week 16. This time frame defines the blinded, comparative phase of the study where the majority of patients remained on their original randomized assignment and exposure between ruxolitinib and hydroxyurea was similar.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy. HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.

    Reporting group title
    Hydroxyurea
    Reporting group description
    		 Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria. Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose. When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.

    Serious adverse events
    		 Ruxolitinib Hydroxyurea
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 54 (9.26%)
    4 / 56 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Hemoglobin decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial occlusive disease
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spondylolisthesis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Ruxolitinib Hydroxyurea
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 54 (92.59%)
    45 / 56 (80.36%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 56 (7.14%)
         occurrences all number
    2
    4
    Hypotension
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 56 (5.36%)
         occurrences all number
    3
    3
    Chest pain
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    Fatigue
         subjects affected / exposed
    11 / 54 (20.37%)
    6 / 56 (10.71%)
         occurrences all number
    12
    7
    Pyrexia
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 56 (1.79%)
         occurrences all number
    2
    2
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 56 (3.57%)
         occurrences all number
    3
    2
    Dyspnoea
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    Epistaxis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    5
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3
    Disturbance in attention
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 56 (1.79%)
         occurrences all number
    2
    1
    Insomnia
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 56 (3.57%)
         occurrences all number
    4
    4
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    5
    Weight decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    Weight increased
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 56 (0.00%)
         occurrences all number
    4
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    Palpitations
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 56 (1.79%)
         occurrences all number
    2
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 54 (12.96%)
    5 / 56 (8.93%)
         occurrences all number
    8
    6
    Headache
         subjects affected / exposed
    9 / 54 (16.67%)
    3 / 56 (5.36%)
         occurrences all number
    11
    4
    Paraesthesia
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 56 (3.57%)
         occurrences all number
    2
    4
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    8 / 54 (14.81%)
    5 / 56 (8.93%)
         occurrences all number
    11
    6
    Leukopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    1
    6
    Lymphadenopathy
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    Neutropenia
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
         occurrences all number
    1
    5
    Thrombocytopenia
         subjects affected / exposed
    2 / 54 (3.70%)
    5 / 56 (8.93%)
         occurrences all number
    2
    6
    Thrombocytosis
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 56 (1.79%)
         occurrences all number
    2
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 56 (3.57%)
         occurrences all number
    3
    2
    Abdominal pain
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 56 (5.36%)
         occurrences all number
    4
    3
    Abdominal pain upper
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Constipation
         subjects affected / exposed
    4 / 54 (7.41%)
    7 / 56 (12.50%)
         occurrences all number
    4
    8
    Diarrhoea
         subjects affected / exposed
    5 / 54 (9.26%)
    11 / 56 (19.64%)
         occurrences all number
    5
    17
    Dry mouth
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    6 / 54 (11.11%)
    3 / 56 (5.36%)
         occurrences all number
    6
    5
    Stomatitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    1
    3
    Vomiting
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    Erythema
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    1
    4
    Hyperhidrosis
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 56 (3.57%)
         occurrences all number
    4
    3
    Night sweats
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    Pruritus
         subjects affected / exposed
    6 / 54 (11.11%)
    6 / 56 (10.71%)
         occurrences all number
    11
    10
    Rash
         subjects affected / exposed
    6 / 54 (11.11%)
    0 / 56 (0.00%)
         occurrences all number
    7
    0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Back pain
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 56 (7.14%)
         occurrences all number
    1
    4
    Muscle spasms
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 56 (5.36%)
         occurrences all number
    5
    3
    Myalgia
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 56 (1.79%)
         occurrences all number
    2
    2
    Neck pain
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 56 (3.57%)
         occurrences all number
    4
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 54 (7.41%)
    1 / 56 (1.79%)
         occurrences all number
    4
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3
    Hyperkalaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2012
    Amendment 1 was issued before the Protocol was submitted to sites or health authorities and before any subjects had received study drug. This was the first version of the Protocol released for subject participation.
    01 Jul 2013
    The primary purpose of the amendment was the following: • Include additional exploratory objectives and endpoints to evaluate Hct control, complete hematologic remission, and palpable spleen length in the study population. • Revise prior phlebotomy inclusion criteria for those subjects with splenomegaly. • Provide specific requirements for study discontinuation for disease progression. • Provide more explicit guidelines for laboratory assessment frequency in the case of dose titrations or temporary interruptions.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27858987
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