ID

18884

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).

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  1. 11/23/16 11/23/16 -
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November 23, 2016

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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Blood/ Urinanalysis 2009-011417-24 DRKS00000657

English

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Blood/ Urinanalysis 2009-011417-24

1 forms  
Laboratory results Blood chemistry
Description

Laboratory results Blood chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Please mark if evaluation was not done
Description

Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0220825
Was pateint fasting?
Description

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Name of laboratory
Description

Name of laboratory

Data type

text

Alias
UMLS CUI [1]
C3258037
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
Chloride
Description

Chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
Calcium
Description

Calcium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201925
mmol/L
Bicarbonate
Description

Bicarbonate

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202059
mmol/L
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
BUN or Urea
Description

BUN or Urea

Data type

integer

Alias
UMLS CUI [1]
C0005845
UMLS CUI [2]
C0523961
BUN or Urea
Description

BUN or Urea specification

Data type

float

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1522609
UMLS CUI [2,1]
C0523961
UMLS CUI [2,2]
C1522609
Uric acid
Description

Uric acid

Data type

float

Alias
UMLS CUI [1]
C0041980
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Total Protein
Description

Total Protein

Data type

float

Alias
UMLS CUI [1]
C0555903
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
sGOT
Description

sGOT

Data type

float

Alias
UMLS CUI [1]
C0201899
sGPT
Description

sGPT

Data type

float

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850
Triglycerides
Description

Triglycerides

Data type

float

Alias
UMLS CUI [1]
C0202236
Cholesterol
Description

Cholesterol

Data type

float

Alias
UMLS CUI [1]
C1445957
Relevant findings within the laboratory values
Description

Relevant findings within the laboratory values

Data type

boolean

Alias
UMLS CUI [1]
C0587081
Urinanalysis
Description

Urinanalysis

Alias
UMLS CUI-1
C0042014
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413
YYYY-MM-DD
pH
Description

Urine pH

Data type

float

Alias
UMLS CUI [1]
C0042044
Protein
Description

Urine Protein

Data type

integer

Alias
UMLS CUI [1]
C0262923
Glucose
Description

Urine Glucose

Data type

integer

Alias
UMLS CUI [1]
C0004076
Blood
Description

Hematuria

Data type

integer

Alias
UMLS CUI [1]
C0018965
Ketones
Description

Urine Ketones

Data type

integer

Alias
UMLS CUI [1]
C1991100
Nitrites
Description

Urine Nitrites

Data type

integer

Alias
UMLS CUI [1]
C0580333
Urine Leucocytes
Description

Urine Leucocytes

Data type

integer

Alias
UMLS CUI [1]
C1256582
Relevant findings within the laboratory values
Description

Relevant findings within the laboratory values: Urinanalysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
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Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V4) Blood/ Urinanalysis 2009-011417-24

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory results Blood chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Evaluation
Item
Please mark if evaluation was not done
boolean
C0220825 (UMLS CUI [1])
Fasting
Item
Was pateint fasting?
boolean
C0015663 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Name of laboratory
Item
Name of laboratory
text
C3258037 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Item
BUN or Urea
integer
C0005845 (UMLS CUI [1])
C0523961 (UMLS CUI [2])
BUN or Urea
Code List
BUN or Urea
CL Item
BUN (1)
CL Item
Urea (2)
BUN or Urea specification
Item
BUN or Urea
float
C0005845 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0523961 (UMLS CUI [2,1])
C1522609 (UMLS CUI [2,2])
Uric acid
Item
Uric acid
float
C0041980 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
sGOT
Item
sGOT
float
C0201899 (UMLS CUI [1])
sGPT
Item
sGPT
float
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Relevant findings within the laboratory values
Item
Relevant findings within the laboratory values
boolean
C0587081 (UMLS CUI [1])
Item Group
Urinanalysis
C0042014 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Urine pH
Item
pH
float
C0042044 (UMLS CUI [1])
Item
Protein
integer
C0262923 (UMLS CUI [1])
Urine Protein
Code List
Protein
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Glucose
integer
C0004076 (UMLS CUI [1])
Urine Glucose
Code List
Glucose
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Blood
integer
C0018965 (UMLS CUI [1])
Hematuria
Code List
Blood
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Ketones
integer
C1991100 (UMLS CUI [1])
Urine Ketones
Code List
Ketones
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Nitrites
integer
C0580333 (UMLS CUI [1])
Urine Nitrites
Code List
Nitrites
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Urine Leucocytes
integer
C1256582 (UMLS CUI [1])
Urine Leucocytes
Code List
Urine Leucocytes
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Relevant findings within the laboratory values: Urinanalysis
Item
Relevant findings within the laboratory values
boolean
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
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