ID

19051

Description

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).

Keywords

Versions (1)
  1. 12/1/16 12/1/16 -
Uploaded on

December 1, 2016

DOI

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License

Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle 2009-011417-24 DRKS00000657

English

WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle 2009-011417-24

1 forms  
Chemotherapy Regimen
Description

Chemotherapy Regimen

Alias
UMLS CUI-1
C0392920
Cycle Week Number: V_
Description

Cycle Week

Data type

integer

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0449788
Start of cycle
Description

Start Day

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0808070
YYYY-MM-DD
Vital signs
Description

Vital signs

Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Syst.
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diast.
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Heart rate

Data type

integer

Measurement units
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Temperature
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
ECG
Description

ECG

Data type

text

Alias
UMLS CUI [1]
C1623258
Physical Examination
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
DLT
Description

Dose-limiting toxicity

Data type

text

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
Concomitant Medication
Description

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
ECOG
Description

ECOG status

Data type

text

Alias
UMLS CUI [1]
C1520224
Haematology
Description

Haematology assessment

Data type

text

Alias
UMLS CUI [1]
C0474523
Urinanalysis
Description

Urinanalysis

Data type

text

Alias
UMLS CUI [1]
C0042014
Biochemistry
Description

Biochemistry assessment

Data type

text

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

WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle 2009-011417-24

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Chemotherapy Regimen
C0392920 (UMLS CUI-1)
Cycle Week
Item
Cycle Week Number: V_
integer
C1302181 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Start Day
Item
Start of cycle
date
C0808070 (UMLS CUI [1])
Item Group
Vital signs
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Syst.
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diast.
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Pulse
integer
C0018810 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
ECG
Item
ECG
text
C1623258 (UMLS CUI [1])
Physical Examination
Item
Physical Examination
text
C0031809 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Dose-limiting toxicity
Item
DLT
text
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
ECOG status
Item
ECOG
text
C1520224 (UMLS CUI [1])
Haematology assessment
Item
Haematology
text
C0474523 (UMLS CUI [1])
Urinanalysis
Item
Urinanalysis
text
C0042014 (UMLS CUI [1])
Biochemistry assessment
Item
Biochemistry
text
C0005477 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
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