Information:
Error:
ID
23411
Description
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00528983
Link
https://clinicaltrials.gov/show/NCT00528983
Keywords
Versions (1)
- 7/4/17 7/4/17 -
Uploaded on
July 4, 2017
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Myelodysplastic Syndromes (MDS) NCT00528983
Eligibility Myelodysplastic Syndromes (MDS) NCT00528983
- StudyEvent: Eligibility
Similar models
Eligibility Myelodysplastic Syndromes (MDS) NCT00528983
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
ID.1
Item
18 years or older.
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
diagnosis of low or int-1 risk mds
boolean
C3463824 (UMLS CUI [1])
ID.3
Item
low platelet count, and/or low hemoglobin, and/or rbc transfusion-dependent and/or platelet transfusion-dependent
boolean
C0032181 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
C1695982 (UMLS CUI [1,4])
C0518015 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
C1695982 (UMLS CUI [1,4])
ID.4
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
ID.5
Item
standard safety inclusion for serum creatinine, ast, alt, bilirubin.
boolean
C0600061 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0005437 (UMLS CUI [1,4])
C0201899 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0005437 (UMLS CUI [1,4])
ID.6
Item
serum bicarbonate greater than or equal to 20 meq/l.
boolean
C0202059 (UMLS CUI [1])
ID.7
Item
use of acceptable birth control.
boolean
C0009862 (UMLS CUI [1])
ID.8
Item
signed, written informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.9
Item
diagnosis of acute pml.
boolean
C0023487 (UMLS CUI [1])
ID.10
Item
previous or concurrent malignancy.
boolean
C0006826 (UMLS CUI [1])
ID.11
Item
prior treatment with azacitidine or other demethylating agents.
boolean
C0004475 (UMLS CUI [1])
ID.12
Item
treatment with any anticancer therapy or investigational drugs within 21 days.
boolean
C0920425 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
ID.13
Item
hypersensitivity to azacitidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0024730 (UMLS CUI [1,3])
C0004475 (UMLS CUI [1,2])
C0024730 (UMLS CUI [1,3])
ID.14
Item
presence of gi disease.
boolean
C0017178 (UMLS CUI [1])
ID.15
Item
active, uncontrolled infection.
boolean
C3714514 (UMLS CUI [1])
ID.16
Item
known human immunodeficiency virus (hiv) or hepatitis c, or known active viral hepatitis b.
boolean
C0019682 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0019196 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
ID.17
Item
breastfeeding or pregnant females;
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
ID.18
Item
presence of serious illness, medical condition, or other medical history which would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
boolean
C0012634 (UMLS CUI [1])
ID.19
Item
current congestive heart failure (ny heart association class iii-iv), unstable angina or angina requiring surgical or medical intervention within 6 months, myocardial infarct within 6 months, or uncontrolled cardiac arrhythmia.
boolean
C0018802 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0003811 (UMLS CUI [1,4])
C0002965 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0003811 (UMLS CUI [1,4])