ID

20601

Descripción

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

Palabras clave

Versiones (1)
  1. 6/3/17 6/3/17 -
Subido en

6 de marzo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia NCT00529763

Inglés

Eligibility Leukemia NCT00529763

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Descripción

informed consent

Tipo de datos

boolean

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

age, gender

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

intolerance to substance; imatinib | Treatment-Resistant; imatinib

Tipo de datos

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
Descripción

ecog

Tipo de datos

boolean

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

liver function

Tipo de datos

boolean

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

renal function

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Exclusion Criteria

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

Female of child bearing age | Contraceptive methods

Tipo de datos

boolean

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

pregnancy, breast feeding

Tipo de datos

boolean

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

subjects eligible for stem cell transplantation

Tipo de datos

boolean

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

serious uncontrolled medical disorder or active infection

Tipo de datos

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
Descripción

cardiovascular disease

Tipo de datos

boolean

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

concurrent incurable malignancy

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

medical history hemorrhage

Tipo de datos

boolean

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

Eligibility Leukemia NCT00529763

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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