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ID
21437
Description
Acute Promyelocytic Leukemia 2006 (APL); ODM derived from: https://clinicaltrials.gov/show/NCT00378365
Link
https://clinicaltrials.gov/show/NCT00378365
Keywords
Versions (2)
- 4/21/17 4/21/17 -
- 4/21/17 4/21/17 -
Uploaded on
April 21, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Leukemia, Promyelocytic, Acute NCT00378365
Eligibility Leukemia, Promyelocytic, Acute NCT00378365
- StudyEvent: Eligibility
Similar models
Eligibility Leukemia, Promyelocytic, Acute NCT00378365
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Acute Promyelocytic Leukemia | t(15;17)(q22;q12) | t(15;17)(PML,RARA) | PML-RARa bcr1 fusion protein, human
Item
diagnosis of apl based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or pml-rara rearrangement with characterization of the bcr subtype (pml-rar characterization).
boolean
C0023487 (UMLS CUI [1])
C1515724 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3493223 (UMLS CUI [4])
C1515724 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3493223 (UMLS CUI [4])
Patients Untreated
Item
untreated patients.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,2])
ID.3
Item
no contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
boolean
ID.4
Item
in female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of atra in early pregnancy).
boolean
Arsenic AND/OR arsenic compound Hypersensitivity Absent
Item
absence of hypersensitivity to arsenic derivatives.
boolean
C0300979 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
ID.6
Item
no qt interval prolongation or complete atria-ventricular block.
boolean
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Patients Treated
Item
patients already treated.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,2])
ID.9
Item
patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to idarubicin.
boolean
ID.10
Item
in female patients: pregnancy or absence of adequate contraceptive methods
boolean
ID.11
Item
qt interval prolongation or complete atria-ventricular block.
boolean
Hypersensitivity Arsenic AND/OR arsenic compound
Item
hypersensitivity to arsenic derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0300979 (UMLS CUI [1,2])
C0300979 (UMLS CUI [1,2])