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18893

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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. 2016-11-23 2016-11-23 -
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23 november 2016

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    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V6) Blood/ Urinanalysis 2009-011417-24 DRKS00000657

    Engelsk

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V6) Blood/ Urinanalysis 2009-011417-24

    1 Formulär  
    Laboratory results Blood chemistry
    Beskrivning

    Laboratory results Blood chemistry

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

    Evaluation

    Datatyp

    boolean

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

    Fasting

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    Date sample taken
    Beskrivning

    Date sample taken

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Name of laboratory
    Beskrivning

    Name of laboratory

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3258037
    Sodium
    Beskrivning

    Sodium

    Datatyp

    float

    Måttenheter
    • mmol/L
    Alias
    UMLS CUI [1]
    C0337443
    mmol/L
    Potassium
    Beskrivning

    Potassium

    Datatyp

    float

    Måttenheter
    • mmol/L
    Alias
    UMLS CUI [1]
    C0202194
    mmol/L
    Chloride
    Beskrivning

    Chloride

    Datatyp

    float

    Måttenheter
    • mmol/L
    Alias
    UMLS CUI [1]
    C0201952
    mmol/L
    Calcium
    Beskrivning

    Calcium

    Datatyp

    float

    Måttenheter
    • mmol/L
    Alias
    UMLS CUI [1]
    C0201925
    mmol/L
    Bicarbonate
    Beskrivning

    Bicarbonate

    Datatyp

    float

    Måttenheter
    • mmol/L
    Alias
    UMLS CUI [1]
    C0202059
    mmol/L
    Creatinine
    Beskrivning

    Creatinine

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201976
    BUN or Urea
    Beskrivning

    BUN or Urea

    Datatyp

    integer

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

    BUN or Urea specification

    Datatyp

    float

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

    Uric acid

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0041980
    Albumin
    Beskrivning

    Albumin

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201838
    Total Protein
    Beskrivning

    Total Protein

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0555903
    Total Bilirubin
    Beskrivning

    Total Bilirubin

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201913
    sGOT
    Beskrivning

    sGOT

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201899
    sGPT
    Beskrivning

    sGPT

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201836
    Alkaline Phosphatase
    Beskrivning

    Alkaline Phosphatase

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201850
    Triglycerides
    Beskrivning

    Triglycerides

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0202236
    Cholesterol
    Beskrivning

    Cholesterol

    Datatyp

    float

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

    Relevant findings within the laboratory values

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0587081
    Urinanalysis
    Beskrivning

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Date sample taken
    Beskrivning

    Date sample taken

    Datatyp

    date

    Måttenheter
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1302413
    YYYY-MM-DD
    pH
    Beskrivning

    Urine pH

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0042044
    Protein
    Beskrivning

    Urine Protein

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0262923
    Glucose
    Beskrivning

    Urine Glucose

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0004076
    Blood
    Beskrivning

    Hematuria

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0018965
    Ketones
    Beskrivning

    Urine Ketones

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1991100
    Nitrites
    Beskrivning

    Urine Nitrites

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0580333
    Urine Leucocytes
    Beskrivning

    Urine Leucocytes

    Datatyp

    integer

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

    Relevant findings within the laboratory values: Urinanalysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    Tillbaka till toppen

    Similar models

    WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V6) Blood/ Urinanalysis 2009-011417-24

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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