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Eligibility Criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Eligibility question
Beschrijving

Eligibility question

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

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

Datatype

text

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

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).
Beschrijving

Written informed consent, consent from guardian, assent from children

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Prior ITP therapy refractory/relapsed

Datatype

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
Beschrijving

Platelet count

Datatype

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
Beschrijving

Previous therapy for ITP with immunoglobulins

Datatype

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
Beschrijving

Concomitant ITP medication

Datatype

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
Beschrijving

Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide

Datatype

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
Beschrijving

PT, aPTT, normal range

Datatype

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
Beschrijving

Complete blood count, no other hematological disorder

Datatype

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%
Beschrijving

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

Datatype

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).
Beschrijving

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).

Datatype

boolean

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

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)
Beschrijving

Other abnormality than ITP, other medical condition or circumstance

Datatype

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
Beschrijving

Concurrent or past malignant disease

Datatype

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
Beschrijving

Continuation of current therapy

Datatype

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
Beschrijving

Recent Investigational drug

Datatype

boolean

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

History of platelet agglutination abnormality

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Evans syndrome

Datatype

boolean

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

Inherited thrombocytopenia (MYH-9 disorders)

Datatype

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
Beschrijving

Recent treatment with drugs affect platelet function, anti-coagulants

Datatype

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
Beschrijving

Prior eltrombopag, any other thrombopoietin receptor agonist

Datatype

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
Beschrijving

inability/unwillingness for blood or urine specimen for pregnancy testing

Datatype

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
Beschrijving

Pregnancy, lactating

Datatype

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
Beschrijving

Social security category

Datatype

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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Similar models

Eligibility Criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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