Information:
Fel:
ID
23412
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00519090
Nyckelord
Versioner (1)
- 2017-07-04 2017-07-04 -
Uppladdad den
4 juli 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Myelogenous Leukemia NCT00519090
Eligibility Myelogenous Leukemia NCT00519090
- StudyEvent: Eligibility
Similar models
Eligibility Myelogenous Leukemia NCT00519090
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
C0935989 (UMLS CUI [1,2])
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])
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])
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])
C1512693 (UMLS CUI [1,2])