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    Clinical Trial Results:
    An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

    Summary
    EudraCT number
    2004-000172-13
    Trial protocol
    GB   DE   BE   AT   CZ   IT  
    Global end of trial date
    26 Jan 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20030213
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00116688
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Amgen, Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.
    Protection of trial subjects
    This study was conducted in accordance with the principles of the US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations and guidelines. Before any subject participated in the study, the investigator was to obtain written informed consent and/or assent for the pediatric population from the subject following adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study. Informed consent was to be obtained before any protocol-specific screening procedures or administration of romiplostim. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). No subjects were recruited into the study and no investigational product (IP) was shipped until the IRB/IEC gave written approval of the protocol and ICF and Amgen received copies of these approvals.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Aug 2004
    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: 17
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 200
    Worldwide total number of subjects
    313
    EEA total number of subjects
    92
    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)
    1
    Children (2-11 years)
    11
    Adolescents (12-17 years)
    9
    Adults (18-64 years)
    208
    From 65 to 84 years
    77
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled from 2 August 2004 through 15 April 2009

    Pre-assignment
    Screening details
    To be eligible for the study, subjects were required to have previously completed a romiplostim ITP study. The only current ITP treatments permitted were corticosteroids, azathioprine, and/or danazol administered at a constant dose and schedule.

    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
    Romiplostim
    Arm description
    Romiplostim was administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim was administered to pediatric participants subcutaneously weekly at doses up to 10 μg/kg based on platelet counts.
    Arm type
    Experimental

    Investigational medicinal product name
    Romiplostim
    Investigational medicinal product code
    AMG 531
    Other name
    Nplate
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection

    Number of subjects in period 1
    Romiplostim
    Started
    313
    Received study medication
    311
    Completed
    217
    Not completed
    96
         Consent withdrawn by subject
    28
         Physician decision
    7
         Other
    11
         'Death '
    15
         Pregnancy
    1
         Adverse event
    11
         Lost to follow-up
    3
         Protocol deviation
    1
         Protocol-specified criteria
    3
         Requirement for alternative therapy
    12
         Noncompliance
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Romiplostim
    Reporting group description
    Romiplostim was administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim was administered to pediatric participants subcutaneously weekly at doses up to 10 μg/kg based on platelet counts.

    Reporting group values
    Romiplostim Total
    Number of subjects
    313 313
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    51.3 ± 19.7 -
    Gender, Male/Female
    Units: Participants
        Female
    190 190
        Male
    123 123
    Race, Customized
    Units: Subjects
        Black or African American
    16 16
        White or Caucasian
    259 259
        Hispanic or Latino
    25 25
        Asian
    9 9
        Japanese
    1 1
        American Indian or Alaska Native
    1 1
        Native Hawaiian or Other Pacific Islander
    1 1
        Other
    1 1
    Subject analysis sets

    Subject analysis set title
    Romiplostim in Adults
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Romiplostim was administered to adult participants subcutaneously weekly at doses up to 30 μg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 μg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 μg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 μg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 μg/kg.

    Subject analysis set title
    Romiplostim in Pediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Romiplostim was administered to pediatric participants subcutaneously weekly at doses up to 10 μg/kg based on platelet counts.

    Subject analysis sets values
    Romiplostim in Adults Romiplostim in Pediatric Population
    Number of subjects
    292
    21
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    54.2 ± 16.9
    10.2 ± 5.1
    Gender, Male/Female
    Units: Participants
        Female
    184
    6
        Male
    108
    15
    Race, Customized
    Units: Subjects
        Black or African American
    13
    3
        White or Caucasian
    246
    13
        Hispanic or Latino
    21
    4
        Asian
    9
    0
        Japanese
    1
    0
        American Indian or Alaska Native
    1
    0
        Native Hawaiian or Other Pacific Islander
    1
    0
        Other
    0
    1

    End points

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    End points reporting groups
    Reporting group title
    Romiplostim
    Reporting group description
    Romiplostim was administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim was administered to pediatric participants subcutaneously weekly at doses up to 10 μg/kg based on platelet counts.

    Subject analysis set title
    Romiplostim in Adults
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Romiplostim was administered to adult participants subcutaneously weekly at doses up to 30 μg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 μg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 μg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 μg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 μg/kg.

    Subject analysis set title
    Romiplostim in Pediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Romiplostim was administered to pediatric participants subcutaneously weekly at doses up to 10 μg/kg based on platelet counts.

    Primary: Number of Participants with Adverse Events

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    End point title
    Number of Participants with Adverse Events [1]
    End point description
    Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once. This endpoint was analyzed in the Safety Analysis Set, composed of all participants who received at least one dose of romiplostim.
    End point type
    Primary
    End point timeframe
    Duration of treatment plus 8 weeks (up to 285 weeks)
    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: The statistical analysis in this open-label extension study was descriptive in nature, no formal hypothesis testing was performed.
    End point values
    Romiplostim in Adults Romiplostim in Pediatric Population
    Number of subjects analysed
    291
    20
    Units: Participants
        number (not applicable)
    284
    19
    No statistical analyses for this end point

    Secondary: Number of Participants with a Platelet Response

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    End point title
    Number of Participants with a Platelet Response
    End point description
    Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications. This endpoint was analyzed in the Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim.
    End point type
    Secondary
    End point timeframe
    Duration of treatment (up to 277 weeks)
    End point values
    Romiplostim in Adults Romiplostim in Pediatric Population
    Number of subjects analysed
    291
    20
    Units: Participants
        number (not applicable)
    275
    20
    No statistical analyses for this end point

    Secondary: Number of Participants with a Reduction or Discontinuation of Concurrent ITP Therapies

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    End point title
    Number of Participants with a Reduction or Discontinuation of Concurrent ITP Therapies
    End point description
    The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study. This endpoint was analyzed in the Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.
    End point type
    Secondary
    End point timeframe
    Duration of treatment (up to 277 weeks)
    End point values
    Romiplostim in Adults Romiplostim in Pediatric Population
    Number of subjects analysed
    37
    2
    Units: Participants
        number (not applicable)
    30
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline in ITP Patient Assessment Questionnaire

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    End point title
    Change from Baseline in ITP Patient Assessment Questionnaire
    End point description
    The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women’s Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL. This endpoint was analyzed in the full analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    Romiplostim in Adults
    Number of subjects analysed
    292
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Physical Health Symptoms (N=209)
    4.2 ± 13.15
        Physical Health Fatigue (N=208)
    3.99 ± 16
        Physical Health Bother (N=204)
    6.43 ± 17.39
        Physical Health Activity (N=208)
    5.23 ± 21.08
        Emotional Health Psychological (N=208)
    4.01 ± 15.81
        Emotional Health Fear (N=209)
    3.48 ± 12.59
        Overall Quality of Life (N=210)
    8.32 ± 19.65
        Social Quality of Life (N=209)
    3.89 ± 13.41
        Women's Reproductive Health (N=71)
    4.51 ± 16.35
        Work Quality of Life (N=75)
    2.78 ± 14.54
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Form 36 (SF-36)

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    End point title
    Change from Baseline in Short Form 36 (SF-36)
    End point description
    The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status. This endpoint was analyzed in the full analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    Romiplostim in Adults
    Number of subjects analysed
    292
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Physical Functioning (N=206)
    1.38 ± 6.34
        Role-Physical (N=208)
    2.03 ± 8.89
        Bodily Pain (N=206)
    0.94 ± 7.99
        General Health Perception (N=208)
    1.31 ± 7.03
        Vitality (N=208)
    1.68 ± 7.47
        Social Functioning (N=208)
    0.52 ± 8.21
        Role-Emotional (N=205)
    1.75 ± 12.22
        Mental Health Index (N=208)
    0.91 ± 7.45
        Physical Component Summary (N=200)
    1.49 ± 6.51
        Mental Component Summary (N=200)
    1.06 ± 8.8
    No statistical analyses for this end point

    Secondary: Change from Baseline in Euroqol-5D (EQ-5D) Index Score

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    End point title
    Change from Baseline in Euroqol-5D (EQ-5D) Index Score
    End point description
    The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status. This endpoint was analyzed in the full analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    Romiplostim in Adults
    Number of subjects analysed
    154
    Units: scores on a scale
        arithmetic mean (standard deviation)
    0.03 ± 0.16
    No statistical analyses for this end point

    Secondary: Change from Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)

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    End point title
    Change from Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)
    End point description
    The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent’s self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status. This endpoint was analyzed in the full analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    Romiplostim in Adults
    Number of subjects analysed
    150
    Units: scores on a scale
        arithmetic mean (standard deviation)
    6.05 ± 14.85
    No statistical analyses for this end point

    Secondary: Patient Global Assessment

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    End point title
    Patient Global Assessment
    End point description
    The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved. This endpoint was analyzed in the full analysis set with available data.
    End point type
    Secondary
    End point timeframe
    Week 1 and Week 48
    End point values
    Romiplostim in Adults
    Number of subjects analysed
    292
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 1 (N=271)
    7.61 ± 2.02
        Week 48 (N=216)
    8.18 ± 1.78
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Romiplostim in Pediatric Population
    Reporting group description
    Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.

    Reporting group title
    Romiplostim in Adults
    Reporting group description
    Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.

    Serious adverse events
    Romiplostim in Pediatric Population Romiplostim in Adults
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    117 / 291 (40.21%)
         number of deaths (all causes)
    0
    16
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer recurrent
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm malignant
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple myeloma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm of orbit
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral arterial stenosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective surgery
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plastic surgery
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cosmetic procedure
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia obstructive
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical complication of implant
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         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 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Megakaryocytes increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count increased
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 291 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac tamponade
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 291 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transverse sinus thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicytopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow reticulin fibrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Evans syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    23 / 291 (7.90%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth impacted
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth loss
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ecchymosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure acute
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         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
    Arthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candidiasis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter bacteraemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis listeria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    8 / 291 (2.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural cellulitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 291 (0.34%)
         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: 5%
    Non-serious adverse events
    Romiplostim in Pediatric Population Romiplostim in Adults
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 20 (95.00%)
    272 / 291 (93.47%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 291 (0.69%)
         occurrences all number
    1
    2
    Haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
    37 / 291 (12.71%)
         occurrences all number
    1
    95
    Haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    10 / 291 (3.44%)
         occurrences all number
    1
    10
    Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    17 / 291 (5.84%)
         occurrences all number
    0
    19
    Surgical and medical procedures
    Ear tube insertion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    22 / 291 (7.56%)
         occurrences all number
    0
    31
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    16 / 291 (5.50%)
         occurrences all number
    2
    20
    Chills
         subjects affected / exposed
    2 / 20 (10.00%)
    12 / 291 (4.12%)
         occurrences all number
    2
    18
    Fatigue
         subjects affected / exposed
    7 / 20 (35.00%)
    93 / 291 (31.96%)
         occurrences all number
    8
    247
    Influenza like illness
         subjects affected / exposed
    1 / 20 (5.00%)
    9 / 291 (3.09%)
         occurrences all number
    1
    9
    Injection site haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    15 / 291 (5.15%)
         occurrences all number
    0
    29
    Injection site haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Injection site pain
         subjects affected / exposed
    1 / 20 (5.00%)
    12 / 291 (4.12%)
         occurrences all number
    1
    17
    Local swelling
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    41 / 291 (14.09%)
         occurrences all number
    0
    83
    Pain
         subjects affected / exposed
    4 / 20 (20.00%)
    32 / 291 (11.00%)
         occurrences all number
    4
    51
    Pyrexia
         subjects affected / exposed
    9 / 20 (45.00%)
    36 / 291 (12.37%)
         occurrences all number
    13
    54
    Swelling
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 20 (5.00%)
    12 / 291 (4.12%)
         occurrences all number
    1
    12
    Latex allergy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 20 (5.00%)
    16 / 291 (5.50%)
         occurrences all number
    1
    33
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 20 (5.00%)
    14 / 291 (4.81%)
         occurrences all number
    1
    18
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    13 / 291 (4.47%)
         occurrences all number
    2
    19
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences all number
    3
    13
    Cough
         subjects affected / exposed
    9 / 20 (45.00%)
    70 / 291 (24.05%)
         occurrences all number
    20
    130
    Dyspnoea
         subjects affected / exposed
    2 / 20 (10.00%)
    22 / 291 (7.56%)
         occurrences all number
    2
    36
    Epistaxis
         subjects affected / exposed
    5 / 20 (25.00%)
    73 / 291 (25.09%)
         occurrences all number
    6
    228
    Nasal congestion
         subjects affected / exposed
    6 / 20 (30.00%)
    30 / 291 (10.31%)
         occurrences all number
    9
    60
    Nasal turbinate abnormality
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal blistering
         subjects affected / exposed
    0 / 20 (0.00%)
    20 / 291 (6.87%)
         occurrences all number
    0
    74
    Oropharyngeal pain
         subjects affected / exposed
    6 / 20 (30.00%)
    50 / 291 (17.18%)
         occurrences all number
    8
    81
    Pharyngeal erythema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 291 (1.72%)
         occurrences all number
    1
    5
    Respiratory tract congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    9 / 291 (3.09%)
         occurrences all number
    1
    22
    Rhinorrhoea
         subjects affected / exposed
    5 / 20 (25.00%)
    26 / 291 (8.93%)
         occurrences all number
    7
    71
    Wheezing
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 291 (1.72%)
         occurrences all number
    1
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    21 / 291 (7.22%)
         occurrences all number
    0
    23
    Depressed mood
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    0 / 20 (0.00%)
    19 / 291 (6.53%)
         occurrences all number
    0
    25
    Emotional disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    41 / 291 (14.09%)
         occurrences all number
    0
    51
    Investigations
    Breath sounds abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Streptococcal identification test positive
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 291 (1.03%)
         occurrences all number
    2
    3
    Arthropod bite
         subjects affected / exposed
    2 / 20 (10.00%)
    6 / 291 (2.06%)
         occurrences all number
    3
    6
    Contusion
         subjects affected / exposed
    8 / 20 (40.00%)
    88 / 291 (30.24%)
         occurrences all number
    18
    336
    Excoriation
         subjects affected / exposed
    3 / 20 (15.00%)
    10 / 291 (3.44%)
         occurrences all number
    4
    12
    Eye injury
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences all number
    1
    7
    Fall
         subjects affected / exposed
    0 / 20 (0.00%)
    19 / 291 (6.53%)
         occurrences all number
    0
    28
    Joint sprain
         subjects affected / exposed
    2 / 20 (10.00%)
    11 / 291 (3.78%)
         occurrences all number
    2
    12
    Laceration
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Limb injury
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 291 (1.37%)
         occurrences all number
    1
    5
    Muscle strain
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 291 (1.37%)
         occurrences all number
    1
    4
    Nerve injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 291 (1.03%)
         occurrences all number
    1
    3
    Procedural pain
         subjects affected / exposed
    2 / 20 (10.00%)
    17 / 291 (5.84%)
         occurrences all number
    2
    18
    Scratch
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 291 (1.37%)
         occurrences all number
    3
    4
    Skin laceration
         subjects affected / exposed
    0 / 20 (0.00%)
    18 / 291 (6.19%)
         occurrences all number
    0
    19
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 20 (10.00%)
    51 / 291 (17.53%)
         occurrences all number
    3
    78
    Headache
         subjects affected / exposed
    9 / 20 (45.00%)
    109 / 291 (37.46%)
         occurrences all number
    17
    411
    Hypoaesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    12 / 291 (4.12%)
         occurrences all number
    1
    15
    Migraine
         subjects affected / exposed
    1 / 20 (5.00%)
    15 / 291 (5.15%)
         occurrences all number
    1
    21
    Paraesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    28 / 291 (9.62%)
         occurrences all number
    0
    35
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    17 / 291 (5.84%)
         occurrences all number
    1
    20
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    2 / 20 (10.00%)
    29 / 291 (9.97%)
         occurrences all number
    2
    51
    Lymphadenopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 291 (1.37%)
         occurrences all number
    1
    4
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 20 (5.00%)
    13 / 291 (4.47%)
         occurrences all number
    1
    16
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences all number
    1
    8
    Conjunctival oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 291 (0.69%)
         occurrences all number
    1
    3
    Photophobia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Scleral haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 20 (5.00%)
    8 / 291 (2.75%)
         occurrences all number
    1
    10
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    17 / 291 (5.84%)
         occurrences all number
    2
    18
    Abdominal pain
         subjects affected / exposed
    3 / 20 (15.00%)
    33 / 291 (11.34%)
         occurrences all number
    3
    53
    Abdominal pain upper
         subjects affected / exposed
    4 / 20 (20.00%)
    21 / 291 (7.22%)
         occurrences all number
    18
    26
    Chapped lips
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    1 / 20 (5.00%)
    26 / 291 (8.93%)
         occurrences all number
    2
    30
    Diarrhoea
         subjects affected / exposed
    2 / 20 (10.00%)
    72 / 291 (24.74%)
         occurrences all number
    2
    129
    Dyspepsia
         subjects affected / exposed
    0 / 20 (0.00%)
    19 / 291 (6.53%)
         occurrences all number
    0
    21
    Gastric disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Gingival bleeding
         subjects affected / exposed
    5 / 20 (25.00%)
    43 / 291 (14.78%)
         occurrences all number
    7
    74
    Haematemesis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    Lip dry
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Lip haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 291 (1.03%)
         occurrences all number
    1
    3
    Mouth haemorrhage
         subjects affected / exposed
    4 / 20 (20.00%)
    21 / 291 (7.22%)
         occurrences all number
    4
    36
    Mouth ulceration
         subjects affected / exposed
    2 / 20 (10.00%)
    4 / 291 (1.37%)
         occurrences all number
    2
    4
    Nausea
         subjects affected / exposed
    4 / 20 (20.00%)
    69 / 291 (23.71%)
         occurrences all number
    4
    113
    Stomatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    9 / 291 (3.09%)
         occurrences all number
    1
    26
    Tongue haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Tooth socket haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 291 (0.69%)
         occurrences all number
    1
    2
    Toothache
         subjects affected / exposed
    1 / 20 (5.00%)
    17 / 291 (5.84%)
         occurrences all number
    1
    27
    Vomiting
         subjects affected / exposed
    7 / 20 (35.00%)
    46 / 291 (15.81%)
         occurrences all number
    14
    64
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 20 (5.00%)
    6 / 291 (2.06%)
         occurrences all number
    1
    8
    Blood blister
         subjects affected / exposed
    0 / 20 (0.00%)
    19 / 291 (6.53%)
         occurrences all number
    0
    40
    Dermatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences all number
    1
    8
    Ecchymosis
         subjects affected / exposed
    1 / 20 (5.00%)
    25 / 291 (8.59%)
         occurrences all number
    1
    35
    Erythema
         subjects affected / exposed
    1 / 20 (5.00%)
    12 / 291 (4.12%)
         occurrences all number
    1
    14
    Petechiae
         subjects affected / exposed
    9 / 20 (45.00%)
    53 / 291 (18.21%)
         occurrences all number
    18
    99
    Pigmentation disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    23 / 291 (7.90%)
         occurrences all number
    0
    45
    Rash
         subjects affected / exposed
    5 / 20 (25.00%)
    44 / 291 (15.12%)
         occurrences all number
    7
    62
    Rash generalised
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Scab
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    Skin discolouration
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 291 (1.37%)
         occurrences all number
    1
    4
    Skin lesion
         subjects affected / exposed
    1 / 20 (5.00%)
    18 / 291 (6.19%)
         occurrences all number
    1
    24
    Swelling face
         subjects affected / exposed
    1 / 20 (5.00%)
    6 / 291 (2.06%)
         occurrences all number
    1
    6
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 20 (0.00%)
    15 / 291 (5.15%)
         occurrences all number
    0
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 20 (25.00%)
    69 / 291 (23.71%)
         occurrences all number
    6
    156
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    54 / 291 (18.56%)
         occurrences all number
    2
    78
    Groin pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Joint swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    16 / 291 (5.50%)
         occurrences all number
    0
    18
    Muscle spasms
         subjects affected / exposed
    1 / 20 (5.00%)
    28 / 291 (9.62%)
         occurrences all number
    1
    62
    Musculoskeletal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    29 / 291 (9.97%)
         occurrences all number
    1
    44
    Myalgia
         subjects affected / exposed
    3 / 20 (15.00%)
    35 / 291 (12.03%)
         occurrences all number
    3
    48
    Neck pain
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 291 (2.41%)
         occurrences all number
    1
    11
    Nodule on extremity
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    2 / 20 (10.00%)
    55 / 291 (18.90%)
         occurrences all number
    6
    97
    Infections and infestations
    Anogenital warts
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Bronchiolitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 20 (5.00%)
    22 / 291 (7.56%)
         occurrences all number
    1
    37
    Conjunctivitis infective
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    2 / 20 (10.00%)
    11 / 291 (3.78%)
         occurrences all number
    2
    18
    Gastroenteritis
         subjects affected / exposed
    2 / 20 (10.00%)
    13 / 291 (4.47%)
         occurrences all number
    2
    16
    Gastroenteritis viral
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 291 (1.72%)
         occurrences all number
    1
    5
    Hepatitis B
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 20 (0.00%)
    23 / 291 (7.90%)
         occurrences all number
    0
    32
    Nasopharyngitis
         subjects affected / exposed
    5 / 20 (25.00%)
    100 / 291 (34.36%)
         occurrences all number
    7
    185
    Oral herpes
         subjects affected / exposed
    1 / 20 (5.00%)
    6 / 291 (2.06%)
         occurrences all number
    2
    12
    Pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    14 / 291 (4.81%)
         occurrences all number
    1
    17
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
    6 / 291 (2.06%)
         occurrences all number
    1
    9
    Rash pustular
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 20 (5.00%)
    38 / 291 (13.06%)
         occurrences all number
    1
    63
    Streptococcal infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Tinea infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 20 (5.00%)
    8 / 291 (2.75%)
         occurrences all number
    1
    10
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 20 (50.00%)
    76 / 291 (26.12%)
         occurrences all number
    16
    136
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    36 / 291 (12.37%)
         occurrences all number
    0
    53
    Varicella
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    2 / 20 (10.00%)
    5 / 291 (1.72%)
         occurrences all number
    3
    7
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 20 (15.00%)
    7 / 291 (2.41%)
         occurrences all number
    4
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 20 (5.00%)
    14 / 291 (4.81%)
         occurrences all number
    1
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2005
    The major changes were: • Self-injection of romiplostim was allowed for subjects on a stable dose of romiplostim. • Dose adjustment and concomitant medications rules were adjusted to allow a scenario more representative of real-life practice, and to give the investigator more flexibility in treating subjects. • Maximum permitted dose of romiplostim was reduced from 30 μg/kg to 15 μg/kg. • Subjects were asked to consent to an optional bone marrow aspirate and biopsy at study entry to assess changes in the bone marrow before continuing romiplostim treatment.
    23 May 2006
    The major changes were: • The drawing and analyzing of additional blood samples for antibody analysis at the request of the investigator or Amgen was allowed. • It was clarified that self-injecting subjects were not required to have weekly platelet counts; subjects who were self-injecting were to have platelet counts assessed every 4 weeks. • Rather than stating specific previous romiplostim ITP studies from which subjects could subsequently enroll into the present study, it was stated that subjects who completed any romiplostim ITP study could enroll into this study; this change allowed subjects in Study 20040209 (Individual Patient Protocol) to transfer into this study. • Maximum permitted dose of romiplostim was reduced from 15 μg/kg to 10 μg/kg. Accumulating data from Study 20020213 indicated that most subjects responded at doses < 10 μg/kg and that subjects not responding at a dose of ≥ 10 μg/kg did not derive additional benefit with a higher dose. • It was specified that for assessment of anti-romiplostim antibody status at screening, a subject’s blood sample from his/her previous study’s EOS visit could be used regardless of the duration since the sample was taken, and that the result of the antibody test was not required prior to enrollment in Study 20030213. • Subjects whose platelet counts remained ≤ 20 x 109/L after receiving romiplostim at ≥ 10 μg/kg for 4 consecutive weeks had to be discontinued from the study. • The signing of informed consent for a subject by a legally acceptable representative was no longer allowed because Amgen’s current policy stated that only the subject could sign informed consent in studies with PRO end points. • The Risks & Discomforts section of the Informed Consent Template was revised.
    18 Oct 2007
    The major changes were: • Updated the protocol to allow for the transfer of pediatric subjects from protocol 20050195 to protocol 20030213, including instructions on dosing of romiplostim in pediatric subjects and dilution of romiplostim. Additional background information on ITP in pediatric patients was also included. • Updated the Dose Adjustment Rules to accurately reflect the current dosing of romiplostim in ITP subjects. • Removed the requirements for subjects to wait until platelet counts had fallen to < 50 x 109/L and to wash out of certain ITP treatments prior to study enrollment. This allowed subjects to enroll into protocol 20030213 immediately after completing their previous romiplostim ITP study. • Clarified and updated the timing of protocol-required procedures and assessments. • Updated the Statistical section of the protocol, including the subset analyses to be completed, the analysis for platelet response, and the analysis in the PRO end points.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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