ID

18888

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

  1. 11/23/16 11/23/16 -
Uploaded on

November 23, 2016

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Creative Commons BY-NC-ND 3.0

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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Blood/ Urinanalysis 2009-011417-24 DRKS00000657

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Blood/ Urinanalysis 2009-011417-24

Laboratory results Blood chemistry
Description

Laboratory results Blood chemistry

Alias
UMLS CUI-1
C1254595 (Laboratory Results)
UMLS CUI-2
C0005774 (Blood Chemical Analysis)
SNOMED
166312007
Please mark if evaluation was not done
Description

Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0220825 (Evaluation)
LOINC
LP36377-7
Was pateint fasting?
Description

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663 (Fasting)
SNOMED
16985007
LOINC
LA11831-7
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413 (Specimen collection date)
SNOMED
399445004
Name of laboratory
Description

Name of laboratory

Data type

text

Alias
UMLS CUI [1]
C3258037 (Performing laboratory name)
LOINC
LP135668-4
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443 (Sodium measurement)
SNOMED
25197003
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202194 (Potassium measurement)
SNOMED
59573005
mmol/L
Chloride
Description

Chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201952 (Chloride measurement)
SNOMED
46511006
mmol/L
Calcium
Description

Calcium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201925 (Calcium measurement)
SNOMED
71878006
mmol/L
Bicarbonate
Description

Bicarbonate

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202059 (Bicarbonate measurement)
SNOMED
88645003
mmol/L
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976 (Creatinine measurement, serum (procedure))
SNOMED
113075003
BUN or Urea
Description

BUN or Urea

Data type

integer

Alias
UMLS CUI [1]
C0005845 (Blood urea nitrogen measurement)
SNOMED
105011006
UMLS CUI [2]
C0523961 (Urea measurement)
SNOMED
105010007
BUN or Urea
Description

BUN or Urea specification

Data type

float

Alias
UMLS CUI [1,1]
C0005845 (Blood urea nitrogen measurement)
SNOMED
105011006
UMLS CUI [1,2]
C1522609 (Numerical value)
UMLS CUI [2,1]
C0523961 (Urea measurement)
SNOMED
105010007
UMLS CUI [2,2]
C1522609 (Numerical value)
Uric acid
Description

Uric acid

Data type

float

Alias
UMLS CUI [1]
C0041980 (uric acid)
SNOMED
1710001
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838 (Albumin measurement)
SNOMED
26758005
Total Protein
Description

Total Protein

Data type

float

Alias
UMLS CUI [1]
C0555903 (Total protein measurement)
SNOMED
304383000
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913 (Bilirubin, total measurement)
SNOMED
359986008
sGOT
Description

sGOT

Data type

float

Alias
UMLS CUI [1]
C0201899 (Aspartate aminotransferase measurement)
SNOMED
45896001
sGPT
Description

sGPT

Data type

float

Alias
UMLS CUI [1]
C0201836 (Alanine aminotransferase measurement)
SNOMED
34608000
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850 (Alkaline phosphatase measurement)
SNOMED
88810008
Triglycerides
Description

Triglycerides

Data type

float

Alias
UMLS CUI [1]
C0202236 (Triglycerides measurement)
SNOMED
14740000
Cholesterol
Description

Cholesterol

Data type

float

Alias
UMLS CUI [1]
C1445957 (Serum total cholesterol measurement)
SNOMED
121868005
Relevant findings within the laboratory values
Description

Relevant findings within the laboratory values

Data type

boolean

Alias
UMLS CUI [1]
C0587081 (Laboratory test finding)
SNOMED
118246004
Urinanalysis
Description

Urinanalysis

Alias
UMLS CUI-1
C0042014 (Urinalysis)
SNOMED
167217005
LOINC
LP32744-2
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413 (Specimen collection date)
SNOMED
399445004
YYYY-MM-DD
pH
Description

Urine pH

Data type

float

Alias
UMLS CUI [1]
C0042044 (Urine pH measurement)
SNOMED
167305006
Protein
Description

Urine Protein

Data type

integer

Alias
UMLS CUI [1]
C0262923 (Urine protein test)
SNOMED
57378007
Glucose
Description

Urine Glucose

Data type

integer

Alias
UMLS CUI [1]
C0004076 (Glucose measurement, urine)
SNOMED
30994003
Blood
Description

Hematuria

Data type

integer

Alias
UMLS CUI [1]
C0018965 (Hematuria)
SNOMED
53298000
Ketones
Description

Urine Ketones

Data type

integer

Alias
UMLS CUI [1]
C1991100 (undefined)
Nitrites
Description

Urine Nitrites

Data type

integer

Alias
UMLS CUI [1]
C0580333 (Urine nitrite)
SNOMED
167585009
Urine Leucocytes
Description

Urine Leucocytes

Data type

integer

Alias
UMLS CUI [1]
C1256582 (Urine Leukocyte Test)
SNOMED
394711007
Relevant findings within the laboratory values
Description

Relevant findings within the laboratory values: Urinanalysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014 (Urinalysis)
SNOMED
167217005
LOINC
LP32744-2
UMLS CUI [1,2]
C0587081 (Laboratory test finding)
SNOMED
118246004

Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Blood/ Urinanalysis 2009-011417-24

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])
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])
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])
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])
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])
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])
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])
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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