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ID
9958
Beschreibung
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)
Stichworte
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Hochgeladen am
9. März 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Diagnostic (1) AMLSG 21-13 NCT02013648
Ähnliche Modelle
Diagnostic (1)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Other African (4)
CL Item
Other, please specify (5)
Other ethnic origin
Item
Other ethnic origin
text
C0015031 (UMLS CUI-1)
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)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI-1)
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
C0018939 (UMLS CUI-1)
CL Item
no (0)
CL Item
yes (please specify) (1)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C2316983 (UMLS CUI-1)
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)
Previous oncological disease
Item
Previous oncological disease
boolean
C0205156 (UMLS CUI-1)
C0205478 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0205478 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C0205265 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0011900 (UMLS CUI-2)
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
C1519384 (UMLS CUI-1)
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)
Previous Chemotherapy or radiation
Item
Previous Chemotherapy or radiation
boolean
C0920425 (UMLS CUI-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)
Splenomegaly
Item
Splenomegaly
boolean
C0038002 (UMLS CUI-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)
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI-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)
Chest X-ray done
Item
Chest X-ray done
boolean
C0202784 (UMLS CUI-1)
Date of chest X-ray
Item
Date of chest X-ray
date
C1406937 (UMLS CUI-1)
Abnormal chest X-ray
Item
Abnormal chest X-ray
boolean
C0436503 (UMLS CUI-1)
Electrocardiogram
Item
ECG done?
boolean
C0013798 (UMLS CUI-1)
ECG Abnormalities
Item
ECG Abnormalities
boolean
C0522055 (UMLS CUI-1)
Echocardiography
Item
Echocardiography done?
boolean
C0013516 (UMLS CUI-1)
Ejection fraction
Item
Ejection fraction
integer
C0232174 (UMLS CUI-1)
Echocardiography abnormal
Item
Echocardiography abnormal
boolean
C0860668 (UMLS CUI-1)
Urinalysis
Item
Urinalysis done?
boolean
C0042014 (UMLS CUI-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)
Pregnancy test
Item
Pregnancy test done?
boolean
C0032976 (UMLS CUI-1)
CL Item
negative (0)
CL Item
positive (no study participation!) (1)
Hepatitis A Test
Item
Hepatitis A Test done?
boolean
C0019159 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
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)
Evidence of acute Hepatitis
Item
Evidence of acute Hepatitis
boolean
C0267797 (UMLS CUI-1)
Hepatitis B Test done
Item
Hepatitis B Test done?
boolean
C1278302 (UMLS CUI-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)
Evidence of acute Hepatitis
Item
Evidence of acute Hepatitis
boolean
C0267797 (UMLS CUI-1)
Evicence of chronic hepatitis
Item
Evicence of chronic hepatitis
boolean
C0019189 (UMLS CUI-1)
Hepatitis C test
Item
Hepatitis C test done?
boolean
C0019196 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
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)
Evidence of acute Hepatitis
Item
Evidence of acute Hepatitis
boolean
C0267797 (UMLS CUI-1)
Evicence of chronic hepatitis
Item
Evicence of chronic hepatitis
boolean
C0019189 (UMLS CUI-1)
HIV test
Item
HIV test done?
boolean
C1321876 (UMLS CUI-1)
CL Item
negative (0)
CL Item
positive (1)
Cytogenetic examination
Item
Cytogenetic examination done?
boolean
C0752095 (UMLS CUI-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)
Concomitant medication
Item
Did Patient take any concomitant medication during time form informed consent till start of Induction I ? If yes please specify on special form
boolean
C2826668 (UMLS CUI-1)
Occurance of Adverse events
Item
Did any Adverse events occure during time from signed informed consent to the start of Induction I? If yes specify on Adverse Events form
boolean
C0877248 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI-1)
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI-1)
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI-1)