ID

20601

Beschrijving

Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00529763

Link

https://clinicaltrials.gov/show/NCT00529763

Trefwoorden

Versies (1)
  1. 06-03-17 06-03-17 -
Geüploaded op

6 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00529763

Engels

Eligibility Leukemia NCT00529763

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
men and women, ages 18 years of age or older
Beschrijving

age, gender

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
subjects with chronic phase (cp) or advanced disease (ad) chronic myeloid leukemia (cml)/ph+ acute lymphoblastic leukemia (ph+ all)
Beschrijving

Chronic phase; Myeloid Leukemia, Chronic | Advanced phase; Myeloid Leukemia, Chronic | Acute lymphocytic leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0457343
UMLS CUI [1,2]
C0023473
UMLS CUI [2,1]
C0205179
UMLS CUI [2,2]
C0023473
UMLS CUI [3]
C0023449
subjects resistant/intolerant to imatinib
Beschrijving

intolerance to substance; imatinib | Treatment-Resistant; imatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C4020575
UMLS CUI [2,2]
C0935989
1. eastern cooperative oncology group (ecog) performance status (ps) score 0-2
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
2. adequate hepatic function
Beschrijving

liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
3. adequate renal function
Beschrijving

renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
4. sodium, potassium, magnesium, phosphorus, calcium higher or equal than the lower limit of normal range
Beschrijving

Sodium measurement | Potassium measurement | Magnesium measurement | Phosphate measurement | Calcium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0337443
UMLS CUI [2]
C0202194
UMLS CUI [3]
C0373675
UMLS CUI [4]
C0523826
UMLS CUI [5]
C0201925
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child bearing potential who are not using adequate birth control
Beschrijving

Female of child bearing age | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0700589
women who are pregnant or breastfeeding
Beschrijving

pregnancy, breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects eligible for stem cell transplantation
Beschrijving

subjects eligible for stem cell transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C1548635
serious uncontrolled medical disorder or active infection
Beschrijving

serious uncontrolled medical disorder or active infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0439801
UMLS CUI [3,2]
C0525058
uncontrolled or significant cardiovascular disease
Beschrijving

cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
concurrent incurable malignancy other than cml
Beschrijving

concurrent incurable malignancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0175969
UMLS CUI [1,3]
C0205420
subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, dasatinib in the past
Beschrijving

imatinib | Interferon | Cytarabine | Antineoplastic Agents | hydroxyurea | dasatinib; Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0010711
UMLS CUI [4]
C0003392
UMLS CUI [5]
C0020402
UMLS CUI [6]
C1455147
UMLS CUI [7]
C1514463
history of significant bleeding unrelated to cml
Beschrijving

medical history hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019080
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Similar models

Eligibility Leukemia NCT00529763

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
age, gender
Item
men and women, ages 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Chronic phase; Myeloid Leukemia, Chronic | Advanced phase; Myeloid Leukemia, Chronic | Acute lymphocytic leukemia
Item
subjects with chronic phase (cp) or advanced disease (ad) chronic myeloid leukemia (cml)/ph+ acute lymphoblastic leukemia (ph+ all)
boolean
C0457343 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C0205179 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
C0023449 (UMLS CUI [3])
intolerance to substance; imatinib | Treatment-Resistant; imatinib
Item
subjects resistant/intolerant to imatinib
boolean
C1744706 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C4020575 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
ecog
Item
1. eastern cooperative oncology group (ecog) performance status (ps) score 0-2
boolean
C1520224 (UMLS CUI [1])
liver function
Item
2. adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
renal function
Item
3. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Sodium measurement | Potassium measurement | Magnesium measurement | Phosphate measurement | Calcium measurement
Item
4. sodium, potassium, magnesium, phosphorus, calcium higher or equal than the lower limit of normal range
boolean
C0337443 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
C0373675 (UMLS CUI [3])
C0523826 (UMLS CUI [4])
C0201925 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Female of child bearing age | Contraceptive methods
Item
women of child bearing potential who are not using adequate birth control
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
pregnancy, breast feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
subjects eligible for stem cell transplantation
Item
subjects eligible for stem cell transplantation
boolean
C1504389 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
serious uncontrolled medical disorder or active infection
Item
serious uncontrolled medical disorder or active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0439801 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
cardiovascular disease
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
concurrent incurable malignancy
Item
concurrent incurable malignancy other than cml
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
imatinib | Interferon | Cytarabine | Antineoplastic Agents | hydroxyurea | dasatinib; Prior Therapy
Item
subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, dasatinib in the past
boolean
C0935989 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0010711 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C1455147 (UMLS CUI [6])
C1514463 (UMLS CUI [7])
medical history hemorrhage
Item
history of significant bleeding unrelated to cml
boolean
C0262926 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
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