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    Clinical Trial Results:
    EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study.

    Summary
    EudraCT number
    2006-000471-14
    Trial protocol
    SI   SE   DE   ES   IE   NL   GR   FR   SK   GB   CZ   DK   IT   FI   AT  
    Global end of trial date
    06 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Jul 2016
    First version publication date
    22 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TRA105325
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00351468
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    Final
    Date of interim/final analysis
    06 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to describe the long-term safety and tolerability of oral eltrombopag treatment of subjects with ITP with or without concomitant ITP medication
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. Rescue medication, defined as the addition of new therapies intended to raise the platelet count, including medications, platelet transfusions, splenectomy or the increase of the dose of any concomitant ITP medications was allowed at any time the investigator deemed it necessary.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 2006
    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
    Australia: 6
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    China: 10
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hong Kong: 19
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    Pakistan: 4
    Country: Number of subjects enrolled
    Peru: 11
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Tunisia: 22
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 62
    Country: Number of subjects enrolled
    Vietnam: 3
    Worldwide total number of subjects
    302
    EEA total number of subjects
    104
    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)
    252
    From 65 to 84 years
    49
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects were previously enrolled in a study of eltrombopag: TRA100773A, TRA100773B, TRA102537/RAISE, or TRA108057/REPEAT. Eligibility of consenting subjects was assessed during the screening period of up to 28 days prior to Day 1 of treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Eltrombopag
    Arm description
    Open-label eltrombopag was supplied in 25 or 50 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
    Arm type
    Experimental

    Investigational medicinal product name
    Eltrombopag
    Investigational medicinal product code
    SB-497115
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing started at 50 mg daily and could be adjusted by the investigator from 25mg to 75 or less than daily depending on platelet counts

    Number of subjects in period 1
    Eltrombopag
    Started
    302
    Subjects from TRA100773A
    51 [1]
    Subjects from TRA100773B
    61 [2]
    Subjects from TRA102537 Raise
    146
    Subjects from TRA108057 Repeat
    43 [3]
    Completed
    135
    Not completed
    167
         Protocol deviation
    3
         Non-compliance
    8
         Lack of efficacy
    32
         Various -follow up w clinical team
    39
         Adverse event, non-fatal
    42
         Consent withdrawn by subject
    39
         Lost to follow-up
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All subjects enrolled in this trial were previously enrolled in one of three eltrombopag trials. Milestones were created to provide number of participants from each of the three trials.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All subjects enrolled in this trial were previously enrolled in one of three eltrombopag trials. Milestones were created to provide number of participants from each of the three trials.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All subjects enrolled in this trial were previously enrolled in one of three eltrombopag trials. Milestones were created to provide number of participants from each of the three trials.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eltrombopag
    Reporting group description
    Open-label eltrombopag was supplied in 25 or 50 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

    Reporting group values
    Eltrombopag Total
    Number of subjects
    302 302
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    252 252
        From 65-84 years
    49 49
        85 years and over
    1 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    48.9 ± 15.61 -
    Gender, Male/Female
    Units: Participants
        Female
    201 201
        Male
    101 101
    Concomitant ITP Medication at Baseline
    Units: Subjects
        Yes
    101 101
        No
    201 201
    Splenectomy Status at Baseline
    Units: Subjects
        Yes
    115 115
        No
    187 187
    Baseline Platelet Count
    Units: Subjects
        <30 Gi/L
    211 211
        30 - 50 Gi/L
    52 52
        > 50 Gi/L
    39 39

    End points

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    End points reporting groups
    Reporting group title
    Eltrombopag
    Reporting group description
    Open-label eltrombopag was supplied in 25 or 50 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

    Primary: Safety and tolerability parameters including, clinicallaboratory tests, ocular examinations, and frequency ofall adverse events

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    End point title
    Safety and tolerability parameters including, clinicallaboratory tests, ocular examinations, and frequency ofall adverse events [1]
    End point description
    See Safety Section
    End point type
    Primary
    End point timeframe
    through study completion estimated to be approximately 5 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was an open-label study and hence no formal statistical hypothesis tests were done.
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Incidences of Adverse Events
    302
    No statistical analyses for this end point

    Secondary: Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication

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    End point title
    Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication
    End point description
    Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses. Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        Baseline Platelet counts >= 30 Gi/L,
    91
        Baseline Platelet counts >= 50 Gi/L,
    42
        Maximum Platelet Count >= 30 Gi/L
    276
        Maximum Platelet Count >= 50 Gi/L
    259
    No statistical analyses for this end point

    Secondary: Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication

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    End point title
    Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication
    End point description
    If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses. Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.
    End point type
    Secondary
    End point timeframe
    Baseline up to Year 7/Week 364
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        Baseline Platelet counts >= 30 Gi/L, n=302
    91
        Baseline Platelet counts >= 50 Gi/L, n=302
    42
        Week 1 Platelet Count >= 30 Gi/L n=293
    172
        Week 1 Platelet Count >= 50 Gi/L n=293
    127
        Week 2 Platelet Count >= 30 Gi/L n=288
    199
        Week 2 Platelet Count >= 50 Gi/L n=288
    165
        Week 3 Platelet Count >= 30 Gi/L n=275
    192
        Week 3 Platelet Count >= 50 Gi/L n=275
    159
        Week 4 Platelet Count >= 30 Gi/L n=275
    192
        Week 4 Platelet Count >= 50 Gi/L n=275
    149
        Week 5 Platelet Count >= 30 Gi/L n=274
    197
        Week 5 Platelet Count >= 50 Gi/L n=274
    159
        Week 6 Platelet Count >= 30 Gi/L n=276
    203
        Week 6 Platelet Count >= 50 Gi/L n=276
    169
        Week 12 Platelet Count >= 30 Gi/L n=197
    147
        Week 12 Platelet Count >= 50 Gi/L n=197
    120
        Month 6/Week 26 Platelet Count >= 30 Gi/L n=130
    93
        Month 6/Week 26 Platelet Count >= 50 Gi/L n=130
    82
        Year 1/Week 52 Platelet Count >= 30 Gi/L n=83
    62
        Year 1/Week 52 Platelet Count >= 50 Gi/L n=83
    50
        Year 1.5/Week 78 Platelet Count >= 30 Gi/L n=63
    47
        Year 1.5/Week78 Platelet Count >= 50 Gi/L n=63
    41
        Year 2/Week 104 Platelet Count >= 30 Gi/L n=59
    46
        Year 2/Week 104 Platelet Count >= 50 Gi/L n=59
    42
        Year 2.5/Week 130 Platelet Count >= 30 Gi/L n=42
    32
        Year 2.5/Week 130 Platelet Count >= 50 Gi/L n=42
    28
        Year 3/Week 156 Platelet Count >= 30 Gi/L n=27
    22
        Year 3/Week 156 Platelet Count >= 50 Gi/L n=27
    19
        Year 3.5/Week 182 Platelet Count >= 30 Gi/L n=23
    19
        Year 3.5/Week 182 Platelet Count >= 50 Gi/L n=23
    17
        Year 4/Week 208 Platelet Count >= 30 Gi/L n=17
    12
        Year 4/Week 208 Platelet Count >= 50 Gi/L n=17
    11
        Year 4.5/Week 234 Platelet Count >= 30 Gi/L n=15
    13
        Year 4.5/Week 234 Platelet Count >= 50 Gi/L n=15
    12
        Year 5/Week 260 Platelet Count >= 30 Gi/L n=9
    6
        Year 5/Week 260 Platelet Count >= 50 Gi/L n=9
    6
        Year 5.5/Week 286 Platelet Count >= 30 Gi/L n=9
    7
        Year 5.5/Week 286 Platelet Count >= 50 Gi/L n=9
    7
        Year 6/Week 312 Platelet Count >= 30 Gi/L n=9
    7
        Year 6/Week 312 Platelet Count >= 50 Gi/L n=9
    7
        Year 6.5/Week 338 Platelet Count >= 30 Gi/L n=5
    3
        Year 6.5/Week 338 Platelet Count >= 50 Gi/L n=5
    3
        Year 7/Week 364 Platelet Count >= 30 Gi/L n=3
    3
        Year 7/Week 364 Platelet Count >= 50 Gi/L n=3
    3
    No statistical analyses for this end point

    Secondary: Number of subjects who responded to eltrombopag in a previous study and who respond to retreatment with a rise in platelet count to either ≥ 50,000/µL or ≥30,000/µL

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    End point title
    Number of subjects who responded to eltrombopag in a previous study and who respond to retreatment with a rise in platelet count to either ≥ 50,000/µL or ≥30,000/µL
    End point description
    - Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL)at last on-treatment assessment. Responders in EXTEND: Platelet count  50 Gi/L and 2 x baseline (BL),  50 Gi/L, and  30 Gi/L at any time. - Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count  50 Gi/L and 2 x baseline,  50 Gi/L, and  30 Gi/L at any time. - Responder in REPEAT: Platelet count 50GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count  50 Gi/L and 2 x baseline (BL),  50 Gi/L, and  30 Gi/L at any time.
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        TRA100773 Responders >= 50 Gi/L in EXTEND, n=51
    49
        TRA100773 >=50 Gi/L and 2 x BL in EXTEND, n=51
    47
        TRA100773 Responders >= 30 Gi/L in EXTEND, n=51
    49
        RAISE Responders >= 50 Gi/L in EXTEND, n=59
    54
        RAISE >= 50 Gi/L and 2 x BL in EXTEND, n=59
    53
        RAISE Responders >= 30 Gi/L in EXTEND, n=51
    55
        REPEAT Responders >= 50 Gi/L in EXTEND, n=36
    33
        REPEAT>= 50 Gi/L and 2 x BL in EXTEND, n=36
    33
        REPEAT Responders >= 30 Gi/L in EXTEND, n=36
    35
    No statistical analyses for this end point

    Secondary: Number of participants with reduction and/or sparing of concomitant ITP therapies, while maintaining a platelet count ≥ 50,000/mL.

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    End point title
    Number of participants with reduction and/or sparing of concomitant ITP therapies, while maintaining a platelet count ≥ 50,000/mL.
    End point description
    Sustain reduct =Sustained reduction[1] Denominator is number of subjects taking an ITP medication at baseline. [2] Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.
    End point type
    Secondary
    End point timeframe
    For at least 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        ITP medication at baseline
    101
        Sustain reduct or stopping at least 1 ITP med [1]
    71
        Permanently stopping at least 1 ITP med [1]
    53
        Sustained reduction[1]
    70
        Maximum sustained reduction ≥ 24 weeks[2]
    66
    No statistical analyses for this end point

    Secondary: Number of subjects who required Rescue Therapy during treatment with eltrombopag.

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    End point title
    Number of subjects who required Rescue Therapy during treatment with eltrombopag.
    End point description
    Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        New ITP medication, n=103
    82
        Increase in dose of ITP med from baseline, n=103
    27
        Platelet transfusion, n=103
    21
        Splenectomy, n=103
    3
    No statistical analyses for this end point

    Secondary: Maximum ITP Bleeding Score at any time during the study during all stages.

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    End point title
    Maximum ITP Bleeding Score at any time during the study during all stages.
    End point description
    The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories:  Grade 0: No bleeding  Grade 1 to 4: Any bleeding  Grade 0 to 1: No clinically significant bleeding  Grade 2 to 4: Clinically significant bleeding
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Participants
        Epistaxis n=300 Grade 0
    204
        Epistaxis n=300 Grade 1
    65
        Epistaxis n=300 Grade 2
    31
        Gastrointestinal n=300 Grade 0
    264
        Gastrointestinal n=300 Grade 1
    26
        Gastrointestinal n=300 Grade 2
    10
        Genitourinary n=300 Grade 0
    262
        Genitourinary n=300 Grade 1
    29
        Genitourinary n=300 Grade 2
    9
        Gynecologic n=108 Grade 0
    68
        Gynecologic n=108 Grade 1
    15
        Gynecologic n=108 Grade 2
    25
        Intracerebral hemorrhage n=300 Grade 0
    297
        Intracerebral hemorrhage n=300 Grade 1
    3
        Intracerebral hemorrhage n=300 Grade 2
    0
        Ocular n=300 Grade 0
    258
        Ocular n=300 Grade 1
    37
        Ocular n=300 Grade 2
    5
        Oral n=300 Grade 0
    191
        Oral n=300 Grade 1
    81
        Oral n=300 Grade 2
    28
        Pulmonary n=300 Grade 0
    287
        Pulmonary n=300 Grade 1
    13
        Pulmonary n=300 Grade 2
    0
        Skin, ecchymosis n=300 Grade 0
    74
        Skin, ecchymosis n=300 Grade 1
    159
        Skin, ecchymosis n=300 Grade 2
    67
        Skin, petechiae n=300 Grade 0
    142
        Skin, petechiae n=300 Grade 1
    126
        Skin, petechiae n=300 Grade 2
    32
    No statistical analyses for this end point

    Secondary: Best Post-Baseline Change in SF-36v2 Questionnaire Score Compared with Baseline - All Patients

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    End point title
    Best Post-Baseline Change in SF-36v2 Questionnaire Score Compared with Baseline - All Patients
    End point description
    The SF-36v2 assessment tool was used to obtain information about subjects’ general health status and health-related quality of life. The tool was to be completed by each subject prior to any other intervention, including physician interaction, at the baseline visit, prior to completion of a Stage, and upon withdrawal or completion of the study. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful,Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases Recall period is the past week prior to administration.
    End point type
    Secondary
    End point timeframe
    Baseline, transitioning between stages, withdrawal/completion of study up to two years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Points on a scale
    arithmetic mean (confidence interval 95%)
        SF-36v2 Physical function (n=273
    12 (9.6 to 14.5)
        SF-36v2 Physical role (n=273)
    14.2 (11.5 to 16.9)
        SF-36v2 Bodily pain (n=273)
    14.5 (11.6 to 17.4)
        SF-36v2 General health (n=273)
    11.1 (9 to 13.1)
        SF-36v2 Vitality (n=290)
    13.9 (11.6 to 16.3)
        SF-36v2 Social function (n=290)
    12.6 (10.2 to 15.1)
        SF-36v2 Emotional role (n=290)
    11.4 (8.7 to 14)
        SF-36v2 Mental health (n=290)
    11.3 (9.4 to 13.3)
        SF-36v2 Physical component summary (n=273)
    5.3 (4.5 to 6.2)
        SF-36v2 Mental component summary (n=290)
    5.8 (4.6 to 6.9)
    No statistical analyses for this end point

    Secondary: Best Post-Baseline Change in the short form of the Motivation and Energy Scale (MEI-SF) compared with Baseline - All Patients

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    End point title
    Best Post-Baseline Change in the short form of the Motivation and Energy Scale (MEI-SF) compared with Baseline - All Patients
    End point description
    The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. n=292
    End point type
    Secondary
    End point timeframe
    Baseline, transitioning between stages, withdrawal/completion of study up to two years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Points on a scale
        arithmetic mean (confidence interval 95%)
    11.2 (9.1 to 13.5)
    No statistical analyses for this end point

    Secondary: Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score Baseline, prior to completion of a Stage, and upon withdrawal or at completion of the study - All Patients

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    End point title
    Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score Baseline, prior to completion of a Stage, and upon withdrawal or at completion of the study - All Patients
    End point description
    The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points. Recall period is past week prior to administration
    End point type
    Secondary
    End point timeframe
    Baseline, prior to completion of a Stage, and upon withdrawal or at completion of the study up to 2 years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Points on a scale
        arithmetic mean (confidence interval 95%)
    6.9 (5.7 to 8.1)
    No statistical analyses for this end point

    Secondary: Best Post-Baseline Change in the FACT-TH6 (Baseline, prior to completion of a Stage, and upon withdrawal or at completion of the study) - All Patients

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    End point title
    Best Post-Baseline Change in the FACT-TH6 (Baseline, prior to completion of a Stage, and upon withdrawal or at completion of the study) - All Patients
    End point description
    The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT‑Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. n=288
    End point type
    Secondary
    End point timeframe
    Baseline, transitioning between stages, withdrawal/completion of study up to two years
    End point values
    Eltrombopag
    Number of subjects analysed
    302
    Units: Points on a scale
        arithmetic mean (confidence interval 95%)
    4 (3.4 to 4.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment + 1 Day: start date was between the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Eltrombopag, Treatment + 1 day
    Reporting group description
    Eltrombopag, Treatment + 1 day

    Reporting group title
    Eltrombopag, gt 1 to 30 Days Post-Therapy
    Reporting group description
    Eltrombopag, gt 1 to 30 Days Post-Therapy

    Serious adverse events
    Eltrombopag, Treatment + 1 day Eltrombopag, gt 1 to 30 Days Post-Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    96 / 302 (31.79%)
    10 / 302 (3.31%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    4 / 302 (1.32%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    B-cell unclassifiable lymphoma low grade
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (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 pain
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Local swelling
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device pain
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (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
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract traumatic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 302 (1.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 302 (1.32%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    4 / 302 (1.32%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    3 / 302 (0.99%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    4 / 302 (1.32%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 302 (0.66%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 302 (1.66%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bone marrow oedema
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 302 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic cyst
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 302 (0.66%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 302 (0.33%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic neuropathy
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    16 / 302 (5.30%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    8 / 17
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroidal neovascularisation
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis haemorrhagic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis acute
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder pain
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (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
    Dehydration
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar state
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 302 (2.65%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 302 (0.99%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Eltrombopag, Treatment + 1 day Eltrombopag, gt 1 to 30 Days Post-Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    253 / 302 (83.77%)
    28 / 302 (9.27%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    22 / 302 (7.28%)
    1 / 302 (0.33%)
         occurrences all number
    26
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    23 / 302 (7.62%)
    0 / 302 (0.00%)
         occurrences all number
    36
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    21 / 302 (6.95%)
    0 / 302 (0.00%)
         occurrences all number
    37
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    32 / 302 (10.60%)
    0 / 302 (0.00%)
         occurrences all number
    51
    0
    Epistaxis
         subjects affected / exposed
    23 / 302 (7.62%)
    2 / 302 (0.66%)
         occurrences all number
    51
    3
    Oropharyngeal pain
         subjects affected / exposed
    27 / 302 (8.94%)
    1 / 302 (0.33%)
         occurrences all number
    45
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    26 / 302 (8.61%)
    1 / 302 (0.33%)
         occurrences all number
    62
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    26 / 302 (8.61%)
    0 / 302 (0.00%)
         occurrences all number
    34
    0
    Headache
         subjects affected / exposed
    86 / 302 (28.48%)
    3 / 302 (0.99%)
         occurrences all number
    178
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    50 / 302 (16.56%)
    4 / 302 (1.32%)
         occurrences all number
    73
    4
    Influenza like illness
         subjects affected / exposed
    25 / 302 (8.28%)
    1 / 302 (0.33%)
         occurrences all number
    37
    1
    Pyrexia
         subjects affected / exposed
    27 / 302 (8.94%)
    2 / 302 (0.66%)
         occurrences all number
    36
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    27 / 302 (8.94%)
    2 / 302 (0.66%)
         occurrences all number
    33
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    18 / 302 (5.96%)
    0 / 302 (0.00%)
         occurrences all number
    34
    0
    Abdominal pain upper
         subjects affected / exposed
    18 / 302 (5.96%)
    1 / 302 (0.33%)
         occurrences all number
    23
    1
    Constipation
         subjects affected / exposed
    26 / 302 (8.61%)
    2 / 302 (0.66%)
         occurrences all number
    33
    2
    Diarrhoea
         subjects affected / exposed
    46 / 302 (15.23%)
    3 / 302 (0.99%)
         occurrences all number
    78
    3
    Nausea
         subjects affected / exposed
    34 / 302 (11.26%)
    1 / 302 (0.33%)
         occurrences all number
    65
    1
    Vomiting
         subjects affected / exposed
    19 / 302 (6.29%)
    2 / 302 (0.66%)
         occurrences all number
    23
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    17 / 302 (5.63%)
    1 / 302 (0.33%)
         occurrences all number
    22
    1
    Rash
         subjects affected / exposed
    25 / 302 (8.28%)
    0 / 302 (0.00%)
         occurrences all number
    48
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    45 / 302 (14.90%)
    0 / 302 (0.00%)
         occurrences all number
    83
    0
    Back pain
         subjects affected / exposed
    39 / 302 (12.91%)
    0 / 302 (0.00%)
         occurrences all number
    63
    0
    Pain in extremity
         subjects affected / exposed
    28 / 302 (9.27%)
    0 / 302 (0.00%)
         occurrences all number
    43
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    25 / 302 (8.28%)
    0 / 302 (0.00%)
         occurrences all number
    34
    0
    Cystitis
         subjects affected / exposed
    16 / 302 (5.30%)
    0 / 302 (0.00%)
         occurrences all number
    24
    0
    Influenza
         subjects affected / exposed
    29 / 302 (9.60%)
    0 / 302 (0.00%)
         occurrences all number
    36
    0
    Nasopharyngitis
         subjects affected / exposed
    74 / 302 (24.50%)
    2 / 302 (0.66%)
         occurrences all number
    156
    2
    Pharyngitis
         subjects affected / exposed
    21 / 302 (6.95%)
    0 / 302 (0.00%)
         occurrences all number
    28
    0
    Sinusitis
         subjects affected / exposed
    20 / 302 (6.62%)
    1 / 302 (0.33%)
         occurrences all number
    36
    1
    Upper respiratory tract infection
         subjects affected / exposed
    69 / 302 (22.85%)
    5 / 302 (1.66%)
         occurrences all number
    135
    5
    Urinary tract infection
         subjects affected / exposed
    32 / 302 (10.60%)
    2 / 302 (0.66%)
         occurrences all number
    63
    2
    Viral infection
         subjects affected / exposed
    23 / 302 (7.62%)
    0 / 302 (0.00%)
         occurrences all number
    35
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2007
    Modification of eligibility criteria for clarity and to meet regulatory feedback. Addition of a secondary endpoint to evaluate retreatment with eltrombopag based on regulatory input. Addition of Liver Chemistry stopping criteria. Addition of platelet count assessment after treatment interruption. Modification of lifestyle wording concerning precautions to direct sunlight and/or UV exposure. Revision of prohibited medications based on new data.
    10 Sep 2007
    Addition of enhanced monitoring for the potential presence of renal toxicity. Inclusion of Tunisian study population regulatory requirements. Addition of bone marrow biopsy for subjects who were dosed with eltrombopag for longer than one year in this study.
    16 Jan 2009
    Requirement for regular bone marrow biopsies (including after 12 and 24 months of treatment), addition of central bone marrow morphology review, and addition of bone marrow biopsy stopping criteria. Requirement of a single ocular exam for subjects who were bilaterally pseudophakic or aphakic. Inclusion of Pharmacogenetic (PGx) sample collection. Modification of the requirements to change between stages of study. Update to the estimate of the number of subjects to be enrolled. Modification of the requirement for transitioning subjects to commercially available medication. Dietary and cation-containing product restrictions were updated to be consistent with current guidelines.
    11 Jun 2009
    A country-specific amendment for the UK to include a definitive date for the end of the study, as required by the UK regulatory authority.
    13 Apr 2010
    Inclusion of thrombophilia risk factor testing, and permitted continuation of subjects following a thrombotic event based upon Investigator assessment of individual risk-benefit assessment. Reduction in the frequency of required investigator/ GlaxoSmithKline (GSK) medical monitor contact, physical exams, ECGs, ocular exams, anti-platelet antibody testing, proteomic sample collection, pharmacokinetic (PK) sampling, renal assessments, and visit frequency. Follow-up requirements for subjects continuing on commercial eltrombopag were reduced. Removal of specific tests within clinical chemistry panel. Removal of ITP Bleeding Score assessment. Removal of phototoxicity precaution statement based on results of photoirritancy study.

    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
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