ID

38410

Descrizione

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Eligibility Criteria form. It has to be filled in for screening.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00908037

Keywords

versioni (3)
  1. 16/10/19 16/10/19 -
  2. 17/10/19 17/10/19 -
  3. 26/11/19 26/11/19 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

16 ottobre 2019

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

    Inglese

    Eligibility Criteria

    1 moduli  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descrizione

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    Eligibility question
    Descrizione

    Eligibility question

    Alias
    UMLS CUI-1
    C1516637
    Did the subject meet all the entry criteria?
    Descrizione

    If you tick No, please select all items in the following itemgroups corresponding to violations of any inclusion/exclusion criteria

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Subjects between 1 year and <18 years of age at Day 1.
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old).
    Descrizione

    Written informed consent, consent from guardian, assent from children

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0023226
    UMLS CUI [2,1]
    C1879749
    UMLS CUI [2,2]
    C1997894
    Confirmed diagnosis of chronic ITP according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
    Descrizione

    Confirmed diagnosis of chronic ITP according to ASH/BCSH, peripheral blood smear, bone marrow

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0398650
    UMLS CUI [1,2]
    C1515949
    UMLS CUI [2]
    C2238079
    UMLS CUI [3]
    C2097112
    Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments.
    Descrizione

    Prior ITP therapy refractory/relapsed

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0035020
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [1,3]
    C0398650
    UMLS CUI [2,1]
    C1514815
    UMLS CUI [2,2]
    C1514463
    UMLS CUI [2,3]
    C0398650
    UMLS CUI [3,1]
    C1512714
    UMLS CUI [3,2]
    C0205394
    UMLS CUI [3,3]
    C0087111
    Day 1 (or within 48 hours prior) platelet count <30 Gi/L
    Descrizione

    Platelet count

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005821
    Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective
    Descrizione

    Previous therapy for ITP with immunoglobulins

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0398650
    UMLS CUI [1,3]
    C0021027
    UMLS CUI [1,4]
    C3242229
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0398650
    UMLS CUI [2,3]
    C0021027
    UMLS CUI [2,4]
    C0205197
    Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1
    Descrizione

    Concomitant ITP medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0398650
    UMLS CUI [2]
    C0001617
    UMLS CUI [3]
    C0004482
    Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective
    Descrizione

    Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0398650
    UMLS CUI [1,3]
    C0037995
    UMLS CUI [1,4]
    C3242229
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0398650
    UMLS CUI [2,3]
    C0037995
    UMLS CUI [2,4]
    C0205197
    UMLS CUI [3,1]
    C1514463
    UMLS CUI [3,2]
    C0398650
    UMLS CUI [3,3]
    C0393022
    UMLS CUI [3,4]
    C3242229
    UMLS CUI [4,1]
    C1514463
    UMLS CUI [4,2]
    C0398650
    UMLS CUI [4,3]
    C0393022
    UMLS CUI [4,4]
    C0205197
    UMLS CUI [5,1]
    C1514463
    UMLS CUI [5,2]
    C0398650
    UMLS CUI [5,3]
    C0010583
    UMLS CUI [5,4]
    C3242229
    UMLS CUI [6,1]
    C1514463
    UMLS CUI [6,2]
    C0398650
    UMLS CUI [6,3]
    C0010583
    UMLS CUI [6,4]
    C0205197
    Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range
    Descrizione

    PT, aPTT, normal range

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C0086715
    UMLS CUI [2,1]
    C0030605
    UMLS CUI [2,2]
    C0086715
    Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder
    Descrizione

    Complete blood count, no other hematological disorder

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009555
    UMLS CUI [1,2]
    C1298908
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0018939
    The following clinical chemistries for the subjects MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%
    Descrizione

    Clinical Chemistries: creatinine, ALT, AST, total bilirubin, AP, total albumin

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201975
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201913
    UMLS CUI [5]
    C0201850
    UMLS CUI [6]
    C0201838
    For subjects of child-bearing potential (after menarche): subject must not be sexually active or is practicing an acceptable method of contraception (documented in chart).
    Descrizione

    Female subjects (or female partners of male subjects) must use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: -Complete abstinence from intercourse; -Intrauterine device (IUD); -Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); -Systemic contraceptives (combined or progesterone only).

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0036899
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease)
    Descrizione

    Other abnormality than ITP, other medical condition or circumstance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2826293
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C4723751
    UMLS CUI [1,4]
    C0398650
    Concurrent or past malignant disease, including myeloproliferative disorder
    Descrizione

    Concurrent or past malignant disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0521116
    UMLS CUI [1,2]
    C1882062
    UMLS CUI [2,1]
    C1444637
    UMLS CUI [2,2]
    C1882062
    UMLS CUI [3]
    C0027022
    Subjects who are not suitable for continuation of their current therapy for at least 7 additional weeks
    Descrizione

    Continuation of current therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C2827774
    Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1
    Descrizione

    Recent Investigational drug

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0013230
    History of platelet agglutination abnormality that prevents reliable measurement of platelet counts
    Descrizione

    History of platelet agglutination abnormality

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0005821
    UMLS CUI [1,3]
    C0001801
    UMLS CUI [1,4]
    C1704258
    Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening
    Descrizione

    Diagnosis of secondary immune thrombocytopenia, HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, HCV infection, evidence of active hepatitis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0332138
    UMLS CUI [1,2]
    C0040034
    UMLS CUI [2]
    C0019693
    UMLS CUI [3]
    C0085278
    UMLS CUI [4]
    C0524909
    UMLS CUI [5]
    C0220847
    UMLS CUI [6,1]
    C0019158
    UMLS CUI [6,2]
    C0205177
    Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis)
    Descrizione

    Evans syndrome

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0272126
    Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders)
    Descrizione

    Inherited thrombocytopenia (MYH-9 disorders)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0439660
    UMLS CUI [1,2]
    C0040034
    UMLS CUI [1,3]
    C1854520
    Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1
    Descrizione

    Recent treatment with drugs affect platelet function, anti-coagulants

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0039798
    UMLS CUI [1,3]
    C0013227
    UMLS CUI [1,4]
    C0392760
    UMLS CUI [1,5]
    C1254881
    UMLS CUI [2]
    C0004057
    UMLS CUI [3]
    C0070166
    UMLS CUI [4]
    C0003211
    UMLS CUI [5]
    C0003280
    Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist
    Descrizione

    Prior eltrombopag, any other thrombopoietin receptor agonist

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C1831905
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2584967
    For female subjects who have reached menarche status, an inability or unwillingness to provide a blood or urine specimen for pregnancy testing
    Descrizione

    inability/unwillingness for blood or urine specimen for pregnancy testing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0032976
    UMLS CUI [2,1]
    C0558080
    UMLS CUI [2,2]
    C0430056
    Female subjects who are pregnant or lactating
    Descrizione

    Pregnancy, lactating

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    In France, a subject is neither affiliated with nor a beneficiary of a social security category
    Descrizione

    Social security category

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1510826
    UMLS CUI [1,2]
    C0037435
    UMLS CUI [2,1]
    C1550502
    UMLS CUI [2,2]
    C0037435
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    Eligibility Criteria

    1 moduli
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Eligibility question
    C1516637 (UMLS CUI-1)
    Item
    Did the subject meet all the entry criteria?
    text
    C1516637 (UMLS CUI [1])
    Prepossess of Entry criteria
    Code List
    Did the subject meet all the entry criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Age
    Item
    Subjects between 1 year and <18 years of age at Day 1.
    boolean
    C0001779 (UMLS CUI [1])
    Written informed consent, consent from guardian, assent from children
    Item
    Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old).
    boolean
    C0021430 (UMLS CUI [1,1])
    C0023226 (UMLS CUI [1,2])
    C1879749 (UMLS CUI [2,1])
    C1997894 (UMLS CUI [2,2])
    Confirmed diagnosis of chronic ITP according to ASH/BCSH, peripheral blood smear, bone marrow
    Item
    Confirmed diagnosis of chronic ITP according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
    boolean
    C0398650 (UMLS CUI [1,1])
    C1515949 (UMLS CUI [1,2])
    C2238079 (UMLS CUI [2])
    C2097112 (UMLS CUI [3])
    Prior ITP therapy refractory/relapsed
    Item
    Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments.
    boolean
    C0035020 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0398650 (UMLS CUI [1,3])
    C1514815 (UMLS CUI [2,1])
    C1514463 (UMLS CUI [2,2])
    C0398650 (UMLS CUI [2,3])
    C1512714 (UMLS CUI [3,1])
    C0205394 (UMLS CUI [3,2])
    C0087111 (UMLS CUI [3,3])
    Platelet count
    Item
    Day 1 (or within 48 hours prior) platelet count <30 Gi/L
    boolean
    C0005821 (UMLS CUI [1])
    Previous therapy for ITP with immunoglobulins
    Item
    Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective
    boolean
    C1514463 (UMLS CUI [1,1])
    C0398650 (UMLS CUI [1,2])
    C0021027 (UMLS CUI [1,3])
    C3242229 (UMLS CUI [1,4])
    C1514463 (UMLS CUI [2,1])
    C0398650 (UMLS CUI [2,2])
    C0021027 (UMLS CUI [2,3])
    C0205197 (UMLS CUI [2,4])
    Concomitant ITP medication
    Item
    Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1
    boolean
    C2347852 (UMLS CUI [1,1])
    C0398650 (UMLS CUI [1,2])
    C0001617 (UMLS CUI [2])
    C0004482 (UMLS CUI [3])
    Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide
    Item
    Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective
    boolean
    C1514463 (UMLS CUI [1,1])
    C0398650 (UMLS CUI [1,2])
    C0037995 (UMLS CUI [1,3])
    C3242229 (UMLS CUI [1,4])
    C1514463 (UMLS CUI [2,1])
    C0398650 (UMLS CUI [2,2])
    C0037995 (UMLS CUI [2,3])
    C0205197 (UMLS CUI [2,4])
    C1514463 (UMLS CUI [3,1])
    C0398650 (UMLS CUI [3,2])
    C0393022 (UMLS CUI [3,3])
    C3242229 (UMLS CUI [3,4])
    C1514463 (UMLS CUI [4,1])
    C0398650 (UMLS CUI [4,2])
    C0393022 (UMLS CUI [4,3])
    C0205197 (UMLS CUI [4,4])
    C1514463 (UMLS CUI [5,1])
    C0398650 (UMLS CUI [5,2])
    C0010583 (UMLS CUI [5,3])
    C3242229 (UMLS CUI [5,4])
    C1514463 (UMLS CUI [6,1])
    C0398650 (UMLS CUI [6,2])
    C0010583 (UMLS CUI [6,3])
    C0205197 (UMLS CUI [6,4])
    PT, aPTT, normal range
    Item
    Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range
    boolean
    C0033707 (UMLS CUI [1,1])
    C0086715 (UMLS CUI [1,2])
    C0030605 (UMLS CUI [2,1])
    C0086715 (UMLS CUI [2,2])
    Complete blood count, no other hematological disorder
    Item
    Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder
    boolean
    C0009555 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0018939 (UMLS CUI [1,4])
    Clinical Chemistries: creatinine, ALT, AST, total bilirubin, AP, total albumin
    Item
    The following clinical chemistries for the subjects MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%
    boolean
    C0201975 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201913 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    C0201838 (UMLS CUI [6])
    Child-bearing potential, sexual abstinence or acceptable method of contraception
    Item
    For subjects of child-bearing potential (after menarche): subject must not be sexually active or is practicing an acceptable method of contraception (documented in chart).
    boolean
    C3831118 (UMLS CUI [1,1])
    C0036899 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Other abnormality than ITP, other medical condition or circumstance
    Item
    Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease)
    boolean
    C2826293 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C4723751 (UMLS CUI [1,3])
    C0398650 (UMLS CUI [1,4])
    Concurrent or past malignant disease
    Item
    Concurrent or past malignant disease, including myeloproliferative disorder
    boolean
    C0521116 (UMLS CUI [1,1])
    C1882062 (UMLS CUI [1,2])
    C1444637 (UMLS CUI [2,1])
    C1882062 (UMLS CUI [2,2])
    C0027022 (UMLS CUI [3])
    Continuation of current therapy
    Item
    Subjects who are not suitable for continuation of their current therapy for at least 7 additional weeks
    boolean
    C1298908 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C2827774 (UMLS CUI [1,3])
    Recent Investigational drug
    Item
    Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1
    boolean
    C0332185 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    History of platelet agglutination abnormality
    Item
    History of platelet agglutination abnormality that prevents reliable measurement of platelet counts
    boolean
    C0262926 (UMLS CUI [1,1])
    C0005821 (UMLS CUI [1,2])
    C0001801 (UMLS CUI [1,3])
    C1704258 (UMLS CUI [1,4])
    Diagnosis of secondary immune thrombocytopenia, HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, HCV infection, evidence of active hepatitis
    Item
    Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening
    boolean
    C0332138 (UMLS CUI [1,1])
    C0040034 (UMLS CUI [1,2])
    C0019693 (UMLS CUI [2])
    C0085278 (UMLS CUI [3])
    C0524909 (UMLS CUI [4])
    C0220847 (UMLS CUI [5])
    C0019158 (UMLS CUI [6,1])
    C0205177 (UMLS CUI [6,2])
    Evans syndrome
    Item
    Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis)
    boolean
    C0272126 (UMLS CUI [1])
    Inherited thrombocytopenia (MYH-9 disorders)
    Item
    Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders)
    boolean
    C0439660 (UMLS CUI [1,1])
    C0040034 (UMLS CUI [1,2])
    C1854520 (UMLS CUI [1,3])
    Recent treatment with drugs affect platelet function, anti-coagulants
    Item
    Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1
    boolean
    C0332185 (UMLS CUI [1,1])
    C0039798 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    C0392760 (UMLS CUI [1,4])
    C1254881 (UMLS CUI [1,5])
    C0004057 (UMLS CUI [2])
    C0070166 (UMLS CUI [3])
    C0003211 (UMLS CUI [4])
    C0003280 (UMLS CUI [5])
    Prior eltrombopag, any other thrombopoietin receptor agonist
    Item
    Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist
    boolean
    C1514463 (UMLS CUI [1,1])
    C1831905 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2584967 (UMLS CUI [2,3])
    inability/unwillingness for blood or urine specimen for pregnancy testing
    Item
    For female subjects who have reached menarche status, an inability or unwillingness to provide a blood or urine specimen for pregnancy testing
    boolean
    C0558080 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0032976 (UMLS CUI [1,3])
    C0558080 (UMLS CUI [2,1])
    C0430056 (UMLS CUI [2,2])
    Pregnancy, lactating
    Item
    Female subjects who are pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Social security category
    Item
    In France, a subject is neither affiliated with nor a beneficiary of a social security category
    boolean
    C1510826 (UMLS CUI [1,1])
    C0037435 (UMLS CUI [1,2])
    C1550502 (UMLS CUI [2,1])
    C0037435 (UMLS CUI [2,2])
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