Information:
Fel:
ID
18871
Beskrivning
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).
Nyckelord
Versioner (2)
- 2016-11-18 2016-11-18 -
- 2016-11-23 2016-11-23 -
Uppladdad den
23 november 2016
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24 DRKS00000657
WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24
Similar models
WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Screening Date
Item
Screening Date
date
C0011008 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
CL Item
Caucasien (1)
CL Item
Black (2)
CL Item
other (3)
Ethnicity Specification
Item
Ethnicity - when other:
text
C0015031 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Screening: physical examination, - concomitant therapies, concomitant diseases
C0031809 (UMLS CUI-1)
C1707479 (UMLS CUI-3)
C0243087 (UMLS CUI-5)
C1707479 (UMLS CUI-3)
C0243087 (UMLS CUI-5)
CL Item
not pathologic (0)
CL Item
pathologic (1)
Adverse event
Item
Adverse events
boolean
C0877248 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
CL Item
Fully active (0)
CL Item
80-90% (1)
CL Item
60-70% (2)
CL Item
40-50% (3)
CL Item
10-30% (4)
CL Item
Dead (5)
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Tumor biopsy
Item
Tumor biopsies (optional)
boolean
C0677862 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,2])
Paraffin Embedded Tissue
Item
Collection of paraffin blocks/ slides
boolean
C1519524 (UMLS CUI [1])
RECIST
Item
CT/MRI tumor evaluation (RECIST)
boolean
C1709926 (UMLS CUI [1])
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Date of first diagnosis
Item
Date of first diagnosis
date
C2316983 (UMLS CUI [1])
Location of primary tumor
Item
Location of primary tumor
text
C0677930 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
Size of primary tumor
Item
Size of primary tumor
text
C1302656 (UMLS CUI [1])
Item
Number of mitoses
integer
C0026255 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
CL Item
low (<=5 hpf) (0)
CL Item
high (> 5-50 hpf) (1)
CL Item
localized (0)
CL Item
metastatic (1)