ID

23412

Beschrijving

Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP); ODM derived from: https://clinicaltrials.gov/show/NCT00519090

Link

https://clinicaltrials.gov/show/NCT00519090

Trefwoorden

  1. 4/7/17 4/7/17 -
Geüploaded op

4 de julio de 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Myelogenous Leukemia NCT00519090

Eligibility Myelogenous Leukemia NCT00519090

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031526
UMLS CUI [1,2]
C0023473
patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as: 6 to < 12 months of treatment and -have 36 - 95% ph+ metaphases, or 12 to <18 months of treatment and have 1 - 35% ph+ metaphases (standard cytogenetics, no fish [fluorescence in situ hybridization] analysis was allowed).
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C4055171
UMLS CUI [1,2]
C0935989
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who have received more than 18 months of imatinib therapy
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1,1]
C4050364
UMLS CUI [1,2]
C4055169
prior treatment with greater than 400 mg/day imatinib.
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
uncontrolled or significant cardiovascular disease.
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C0010207
currently taking certain medications that could affect the rhythm of your heart.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0041755
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1512693

Similar models

Eligibility Myelogenous Leukemia NCT00519090

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
boolean
C0031526 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
ID.2
Item
patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as: 6 to < 12 months of treatment and -have 36 - 95% ph+ metaphases, or 12 to <18 months of treatment and have 1 - 35% ph+ metaphases (standard cytogenetics, no fish [fluorescence in situ hybridization] analysis was allowed).
boolean
C4055171 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.5
Item
patient who have received more than 18 months of imatinib therapy
boolean
C0935989 (UMLS CUI [1])
ID.6
Item
patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
boolean
C4050364 (UMLS CUI [1,1])
C4055169 (UMLS CUI [1,2])
ID.7
Item
prior treatment with greater than 400 mg/day imatinib.
boolean
C0935989 (UMLS CUI [1])
ID.8
Item
uncontrolled or significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
ID.9
Item
severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
boolean
C0012634 (UMLS CUI [1])
ID.10
Item
use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
boolean
C0010207 (UMLS CUI [1])
ID.11
Item
currently taking certain medications that could affect the rhythm of your heart.
boolean
C0013227 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
ID.12
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])

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