Information:
Fel:
ID
23209
Beskrivning
Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00528450
Länk
https://clinicaltrials.gov/show/NCT00528450
Nyckelord
Versioner (1)
- 2017-06-28 2017-06-28 -
Uppladdad den
28 juni 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Leukemia NCT00528450
Eligibility Leukemia NCT00528450
- StudyEvent: Eligibility
Similar models
Eligibility Leukemia NCT00528450
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ID.1
Item
morphologic diagnosis of acute promyelocytic leukemia (apl), confirmed by one of the following:
boolean
C0023487 (UMLS CUI [1])
ID.2
Item
demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (fish)
boolean
C4287946 (UMLS CUI [1])
ID.3
Item
positive pml-rarα transcript by reverse transcriptase-polymerase chain reaction (rt-pcr) assay
boolean
C3475382 (UMLS CUI [1])
ID.4
Item
patients with cns involvement by apl are eligible
boolean
C0085136 (UMLS CUI [1])
ID.6
Item
karnofsky performance status 60-100%
boolean
C0206065 (UMLS CUI [1])
ID.7
Item
creatinine ≤ 2.0 mg/dl or creatinine clearance > 60 ml/min
boolean
C0010294 (UMLS CUI [1])
ID.8
Item
bilirubin < 2.0 mg/dl (unless attributed to gilbert disease)
boolean
C0005437 (UMLS CUI [1])
ID.9
Item
alkaline phosphatase ≤ 2.5 times the upper limit of normal (uln)
boolean
C0002059 (UMLS CUI [1])
ID.10
Item
ast and alt ≤ 2.5 uln
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
C0001899 (UMLS CUI [1,2])
ID.11
Item
lvef ≥ 50% on echocardiogram or muga scan
boolean
C0428772 (UMLS CUI [1])
ID.12
Item
qtc ≤ 500 msec on baseline ecg
boolean
C0860814 (UMLS CUI [1])
ID.13
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
ID.14
Item
negative pregnancy test
boolean
C0032961 (UMLS CUI [1])
ID.15
Item
fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
boolean
C0009862 (UMLS CUI [1])
ID.16
Item
no active serious infections not controlled by antibiotics
boolean
C3714514 (UMLS CUI [1])
ID.17
Item
no other concurrent active malignancy requiring immediate therapy
boolean
C0006826 (UMLS CUI [1])
ID.18
Item
no clinically significant cardiac disease (new york heart association class iii or iv heart disease), including chronic arrhythmias
boolean
C0018799 (UMLS CUI [1])
ID.19
Item
no pulmonary disease
boolean
C0024115 (UMLS CUI [1])
ID.20
Item
no other serious or life-threatening condition deemed unacceptable by the principal investigator
boolean
C0012634 (UMLS CUI [1])
ID.21
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
ID.22
Item
no prior treatment for apl
boolean
C0023487 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])