ID

22025

Description

Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00324077

Link

https://clinicaltrials.gov/show/NCT00324077

Keywords

  1. 5/15/17 5/15/17 -
  2. 5/15/17 5/15/17 -
Uploaded on

May 15, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00324077

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00324077

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic phase ph+ or bcr-abl positive cml
Description

Chronic-Phase Myeloid Leukemia Philadelphia chromosome positive | Chronic myelogenous leukemia, BCR/ABL positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0856536
UMLS CUI [2]
C1292771
current complete hematologic response to imatinib
Description

imatinib | Complete Hematologic Response

Data type

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2]
C4050175
lack of major molecular response
Description

Molecular Major Response Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C4049637
UMLS CUI [1,2]
C0332268
on imatinib for at least one year
Description

imatinib Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0449238
on the same imatinib dose for at least 6 months
Description

imatinib Dose Same Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0449238
adequate hepatic and renal function
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of accelerated or blast phase cml
Description

Leukemia, Myeloid, Accelerated Phase | Blast Phase

Data type

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C0005699
serious uncontrolled medical disorder or active infection
Description

Disease Uncontrolled Serious | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0009450
significant cardiovascular disease or bleeding disorder
Description

Cardiovascular Disease | Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0005779
concurrent use of medications at risk of causing torsades de pointe
Description

Pharmaceutical Preparations At risk Causing Torsades de points

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C3842160

Similar models

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00324077

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, 18 or older
boolean
C0001779 (UMLS CUI [1])
Chronic-Phase Myeloid Leukemia Philadelphia chromosome positive | Chronic myelogenous leukemia, BCR/ABL positive
Item
chronic phase ph+ or bcr-abl positive cml
boolean
C0023474 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
C1292771 (UMLS CUI [2])
imatinib | Complete Hematologic Response
Item
current complete hematologic response to imatinib
boolean
C0935989 (UMLS CUI [1])
C4050175 (UMLS CUI [2])
Molecular Major Response Lacking
Item
lack of major molecular response
boolean
C4049637 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
imatinib Duration
Item
on imatinib for at least one year
boolean
C0935989 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
imatinib Dose Same Duration
Item
on the same imatinib dose for at least 6 months
boolean
C0935989 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Liver function | Renal function
Item
adequate hepatic and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Leukemia, Myeloid, Accelerated Phase | Blast Phase
Item
history of accelerated or blast phase cml
boolean
C0023472 (UMLS CUI [1])
C0005699 (UMLS CUI [2])
Disease Uncontrolled Serious | Communicable Disease
Item
serious uncontrolled medical disorder or active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
Cardiovascular Disease | Blood Coagulation Disorder
Item
significant cardiovascular disease or bleeding disorder
boolean
C0007222 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Pharmaceutical Preparations At risk Causing Torsades de points
Item
concurrent use of medications at risk of causing torsades de pointe
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C3842160 (UMLS CUI [1,4])

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