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ID
9871
Description
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel™) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)
Keywords
Versions (11)
- 2/24/15 2/24/15 -
- 2/25/15 2/25/15 -
- 2/25/15 2/25/15 -
- 2/26/15 2/26/15 -
- 2/26/15 2/26/15 -
- 2/26/15 2/26/15 -
- 3/9/15 3/9/15 -
- 3/9/15 3/9/15 -
- 4/23/15 4/23/15 -
- 12/8/15 12/8/15 -
- 9/17/21 9/17/21 -
Uploaded on
February 25, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Diagnostic (1)
Similar models
Diagnostic (1)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CL Item
m (1)
CL Item
f (2)
Height
Item
How tall is the patient?
integer
C0489786 (UMLS CUI-1)
CL Item
Caucasian (1)
CL Item
Asian (2)
CL Item
North african/Arabian/Turk (3)
CL Item
othe african (4)
CL Item
Other, please specify (5)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Temperature
Item
Temperature
integer
C0039476 (UMLS CUI-1)
LDH
Item
LDH
integer
C0202113 (UMLS CUI-1)
Tissue typing done
Item
Tissue typing done
boolean
Number of siblings
Item
Number of siblings
integer
C0557094 (UMLS CUI-1)
Number HLA-identic siblings
Item
Number HLA-identic siblings
integer
C0449788 (UMLS CUI-1)
C0037047 (UMLS CUI-2)
C0019721 (UMLS CUI-3)
C0037047 (UMLS CUI-2)
C0019721 (UMLS CUI-3)
Number HLA-identic siblings
Item
Number HLA-identic siblings
integer
C0449788 (UMLS CUI-1)
C0205280 (UMLS CUI-2)
C0037047 (UMLS CUI-3)
C0019721 (UMLS CUI-4)
C0205280 (UMLS CUI-2)
C0037047 (UMLS CUI-3)
C0019721 (UMLS CUI-4)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C0005558 (UMLS CUI-1)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
FAB-classification of AML
Item
FAB-classification of AML
integer
C0457321 (UMLS CUI-1)
CL Item
de Novo AML (1)
CL Item
therapy induced AML (2)
CL Item
secondary AML after MDS/MPS (3)
Item
Previous hematological disease (MDS/MPS)
integer
C0205156 (UMLS CUI-1)
C0205488 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0205488 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
CL Item
no (0)
CL Item
yes (please specify) (1)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C0005558 (UMLS CUI-1)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
Initial Diagnosis
Item
Initial Diagnosis
text
C0205265 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0011900 (UMLS CUI-2)
Initial Therapy
Item
Initial Therapy
text
C0205265 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI-2)
Item
Previous oncological disease
text
C0205156 (UMLS CUI-1)
C0205478 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0205478 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
CL Item
no (0)
CL Item
yes (please specify) (1)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C0005558 (UMLS CUI-1)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C1279901 (UMLS CUI-2)
C1446409 (UMLS CUI-3)
C2745955 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI-1)
Therapy
Item
Therapy
text
C0087111 (UMLS CUI-1)
Medical history
Item
previous diseases and Baseline symptoms
text
C0262926 (UMLS CUI-1)
Exposure to toxic agents
Item
Exposure to toxic agents, if yes please specify
text
C0853965 (UMLS CUI-1)
Smoking or smoking history
Item
Smoking or smoking history
boolean
C0037369 (UMLS CUI-1)
C1519384 (UMLS CUI-2)
C1519384 (UMLS CUI-2)
Cigarettes per day
Item
Cigarettes per day
integer
C3694146 (UMLS CUI-1)
Smoking years
Item
Number of smoking years
integer
C0449788 (UMLS CUI-1)
C0037369 (UMLS CUI-2)
C0439234 (UMLS CUI-3)
C0037369 (UMLS CUI-2)
C0439234 (UMLS CUI-3)
Item
Previous Chemotherapy or radiation
integer
C0439577 (UMLS CUI-1)
C0445177 (UMLS CUI-2)
C0445177 (UMLS CUI-2)
CL Item
no (0)
CL Item
yes (please specify) (1)
Item
Extramedullary Manifestatation
text
C1517060 (UMLS CUI-1)
C1280464 (UMLS CUI-2)
C1280464 (UMLS CUI-2)
CL Item
no (0)
CL Item
Skin (1)
CL Item
CNS (2)
CL Item
Liver (3)
CL Item
Spleen (4)
CL Item
lymphatic (5)
CL Item
Hyperplasia of gingiva (6)
CL Item
multiple (please specify) (7)
CL Item
other (please specify) (8)
CL Item
no (0)
CL Item
yes (please specify) (1)
Spleen diameter
Item
Maximal spleen diameter, sonographic
integer
C0037993 (UMLS CUI-1)
C1301886 (UMLS CUI-2)
C1301886 (UMLS CUI-2)
Spleen position under costal arch
Item
Spleen position under costal arch
integer
C1148173 (UMLS CUI-1)
CL Item
no (0)
CL Item
yes (please specify) (1)
Liver-diameter
Item
Liver-diameter
integer
C0551956 (UMLS CUI-1)
Liver size below costal arch
Item
Liver size below costal arch
integer
C1148081 (UMLS CUI-1)
Blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI-1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Date of chest X-ray
Item
Date of chest X-ray
date
C0011008 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0817096 (UMLS CUI-3)
C0031809 (UMLS CUI-2)
C0817096 (UMLS CUI-3)
CL Item
no (0)
CL Item
yes (please specify) (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
CL Item
no (0)
CL Item
yes (please specify) (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Ejection fraction
Item
Ejection fraction
integer
C0232174 (UMLS CUI-1)
CL Item
no (0)
CL Item
yes (please specify) (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Urine pH
Item
Urine pH
integer
C1826989 (UMLS CUI-1)
CL Item
normal (0)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
CL Item
normal (0)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
CL Item
no (0)
CL Item
yes (specify date) (1)
Item
Pregnancy test result
integer
C1522602 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
CL Item
negativ (0)
CL Item
positive (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Item
Hepatitis A test result
integer
C0019159 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
CL Item
negativ (0)
CL Item
positive (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Item
Hepatitis B test result
integer
C0019163 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
CL Item
negative (0)
CL Item
positive (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Item
Hepatitis C test result
integer
C0019196 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
CL Item
negative (0)
CL Item
positive (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
negative (0)
CL Item
positive (1)
CL Item
no (0)
CL Item
yes (specify date) (1)
Number of analysed Metaphases
Item
Number of analysed Metaphases
integer
C0237753 (UMLS CUI-1)
C1621812 (UMLS CUI-2)
C1621812 (UMLS CUI-2)
Karyotype
Item
Karyotype
text
C1261273 (UMLS CUI-1)
Item
Did Patient take any concomitant medication during time form informed consent till start of Induction I ?
text
C2826668 (UMLS CUI-1)
Code List
Did Patient take any concomitant medication during time form informed consent till start of Induction I ?
CL Item
no (0)
CL Item
yes (please document on Concomitant Medication Form) (1)
Item
Did any Adverse events occure during time from signed informed consent to the start of Induction I
text
C0877248 (UMLS CUI-1)
Code List
Did any Adverse events occure during time from signed informed consent to the start of Induction I
CL Item
no (0)
CL Item
yes (please document on the Adverse Event form) (1)