ID

18899

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

  1. 2016-11-23 2016-11-23 -
Uppladdad den

23 november 2016

DOI

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Creative Commons BY-NC-ND 3.0

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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24 DRKS00000657

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24

Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Start of Week 7
Beskrivning

Start of week

Datatyp

date

Måttenheter
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C0439230
YYYY-MM-DD
Weight
Beskrivning

Weight

Datatyp

float

Alias
UMLS CUI [1]
C0005910
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
pulse
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Temperature
Beskrivning

Body temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
ECG
Beskrivning

ECG

Datatyp

integer

Alias
UMLS CUI [1]
C1623258
Physical examination
Beskrivning

Physical examination

Datatyp

integer

Alias
UMLS CUI [1]
C0031809
Adverse events
Beskrivning

Adverse event

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
DLT
Beskrivning

Dose-limiting toxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
Concomitant medications
Beskrivning

Concomitant medications

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
ECOG Status
Beskrivning

ECOG Status

Datatyp

integer

Alias
UMLS CUI [1]
C1520224
Hematology
Beskrivning

Hematological Assessment

Datatyp

integer

Alias
UMLS CUI [1,1]
C0279810
UMLS CUI [1,2]
C0220825
Urinanalysis
Beskrivning

Urinanalysis

Datatyp

integer

Alias
UMLS CUI [1]
C0042014
Biochemistry
Beskrivning

Biochemistry assessment

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0220825

Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 2 Week 7 (V8) 2009-011417-24

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Start of week
Item
Start of Week 7
date
C0808070 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
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])
Item
ECG
integer
C1623258 (UMLS CUI [1])
Code List
ECG
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Physical examination
integer
C0031809 (UMLS CUI [1])
Code List
Physical examination
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
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Concomitant medications
Item
Concomitant medications
boolean
C2347852 (UMLS CUI [1])
Item
ECOG Status
integer
C1520224 (UMLS CUI [1])
Code List
ECOG Status
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])
Code List
Hematology
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Urinanalysis
integer
C0042014 (UMLS CUI [1])
Code List
Urinanalysis
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])
Code List
Biochemistry
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)

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