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ID
18885
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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- 23-11-16 23-11-16 -
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23 november 2016
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Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24 DRKS00000657
WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24
Similar models
WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 Week 4 (V5) 2009-011417-24
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Start of cycle
Item
Start of cycle
date
C0808070 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (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])
Heart rate
Item
pulse
integer
C0018810 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
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)
Adverse event
Item
Adverse events
boolean
C0877248 (UMLS CUI [1])
Dose-limiting toxicity
Item
DLT
text
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
Concomitant medications
Item
Concomitant medications
boolean
C2347852 (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)
Item
Hematology
integer
C0279810 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
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)
Item
Biochemistry
integer
C0005477 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
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