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ID
19060
Beschrijving
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).
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Versies (1)
- 02.12.16 02.12.16 -
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2. Dezember 2016
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24 DRKS00000657
WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24
Similar models
WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Examination Date
Item
Date
date
C2826643 (UMLS CUI [1])
CL Item
not pathologic (0)
CL Item
pathologic (1)
Adverse Event
Item
Adverse Event
boolean
C0877248 (UMLS CUI [1])
Dose-limiting toxicity
Item
DLT
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Pulse
integer
C0018810 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (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])
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
pathol. (1)
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