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ID

13545

Beskrivning

Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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Versioner (1)
  1. 2016-02-15 2016-02-15 -
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15 februari 2016

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Creative Commons BY-NC 3.0
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    Visit 7 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

    Engelsk

    Case Report Form (HIPEC) Visit 7

    1 Formulär  
    Visit 7:Day 14 post-surgery
    Beskrivning

    Visit 7:Day 14 post-surgery

    Patient ID
    Beskrivning

    Patient ID

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1269815
    CRF number
    Beskrivning

    CRF number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C0449788
    Date of visit
    Beskrivning

    date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Vital signs, concomitant medication and CTCAE
    Beskrivning

    Vital signs, concomitant medication and CTCAE

    Heart rate count
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood pressure measurement
    Beskrivning

    Blood pressure

    Datatyp

    text

    Måttenheter
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823
    mm/Hg
    Body Temperature
    Beskrivning

    Body Temperature

    Datatyp

    float

    Måttenheter
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Has concomitant medication been subject to change? If `Yes` please fill in Concomitant medication form.
    Beskrivning

    Concomitant agent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
    Beskrivning

    CTCAE

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1516728
    Laboratory results
    Beskrivning

    Laboratory results

    Date of venous blood sampling
    Beskrivning

    First venipuncture of that day

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0190979
    UMLS CUI [1,2]
    C0011008
    Time of laboratory procedure (according to laboratory sheet)
    Beskrivning

    Time of laboratory procedure

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0022885
    Creatinine measurement value
    Beskrivning

    Serologic tests Creatinine

    Datatyp

    integer

    Måttenheter
    • mg/dl
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201975
    mg/dl
    Is Creatinine value within normal range?
    Beskrivning

    Serologic tests Creatinine

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201975
    Are Creatinine measurement findings clinically significant? If `Yes`, please fill in AE- form.
    Beskrivning

    Serologic tests Creatinine

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201975
    Urea measurement value
    Beskrivning

    Serologic tests Urea measurement

    Datatyp

    integer

    Måttenheter
    • mg/dl
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523961
    mg/dl
    Is Urea measurement value within normal range?
    Beskrivning

    Serologic tests Urea measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523961
    Are Urea measurement findings clinically significant? If `Yes`, please fill in AE-Form.
    Beskrivning

    Serologic tests Urea measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523961
    Bilirubin measurement value
    Beskrivning

    Serologic tests Bilirubin measurement

    Datatyp

    integer

    Måttenheter
    • mg/dl
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0344395
    mg/dl
    Is Bilirubin measurement value within normal range?
    Beskrivning

    Serologic tests Bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0344395
    Are Bilirubin measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests Bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0344395
    GPT measurement value
    Beskrivning

    Serologic tests GPT measurement

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201836
    U/l
    Is GPT value within normal range?
    Beskrivning

    Serologic tests GPT measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201836
    Are GPT measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic measurement GPT measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201836
    GOT measurement value
    Beskrivning

    Serologic tests GOT measurement

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201899
    U/l
    Is GOT value within normal range?
    Beskrivning

    Serologic tests GOT measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201899
    Are GOT measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests GOT measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201899
    GGT measurement value
    Beskrivning

    Serologic tests GGT measurement

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0202035
    U/l
    Is GGT measurement within normal range?
    Beskrivning

    Serologic tests GGT Measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0202035
    Are GGT measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests GGT measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0202035
    Albumin measurement value
    Beskrivning

    Serologic tests Albumin measurement

    Datatyp

    integer

    Måttenheter
    • g/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201838
    g/l
    Is Albumin measurement within normal range?
    Beskrivning

    Serologic tests Albumin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201838
    Are Albumin measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests Albumin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201838
    Serum potassium measurement value
    Beskrivning

    Serologic tests serum potassium

    Datatyp

    integer

    Måttenheter
    • mmol/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0302353
    mmol/l
    Is serum potassium measurement value within normal range?
    Beskrivning

    Serologic tests serum potassium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0302353
    Are serum potassium measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests serum potassium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0302353
    Serum sodium measurement value
    Beskrivning

    Serologic tests serum sodium

    Datatyp

    integer

    Måttenheter
    • mmol/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523891
    mmol/l
    Is serum sodium measurement value within normal range?
    Beskrivning

    Serologic tests serum sodium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523891
    Are serum sodium measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic tests serum sodium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0523891
    Serum calcium measurement value
    Beskrivning

    Serologic tests serum calcium

    Datatyp

    integer

    Måttenheter
    • mmol/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0728876
    mmol/l
    Is serum calcium measurement value within normal range?
    Beskrivning

    Serologic tests serum calcium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0728876
    Are serum calcium measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Serologic measurement serum calcium

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0728876
    Serum chloride measurement value
    Beskrivning

    Serologic tests serum chloride

    Datatyp

    integer

    Måttenheter
    • mmol/l
    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C1317978
    mmol/l
    Is serum chloride measurement value within normal range?
    Beskrivning

    Serologic tests serum chloride

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C1317978
    Are serum chloride measurement findings clinically significant? If `Yes` , please fill in AE form.
    Beskrivning

    Serologic tests serum chloride

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C1317978
    Hemoglobin measurement value
    Beskrivning

    Blood cell count: hemoglobin measurement

    Datatyp

    integer

    Måttenheter
    • g/dl
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518015
    g/dl
    Is the hemoglobin measurement value within normal range?
    Beskrivning

    Blood cell count: hemoglobin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518015
    Are hemoglobin measurement findings clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: hemoglobin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518015
    Hematocrit level
    Beskrivning

    Blood cell count hematocrit level

    Datatyp

    integer

    Måttenheter
    • %
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518014
    %
    Is the hematocrit level within normal range?
    Beskrivning

    Blood cell count: Hematocrit level

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518014
    Are findings in hematocrit level clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: Hematocrit level

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0518014
    Erythrocyte measurement value
    Beskrivning

    Blood cell count: erythrocyte measurement

    Datatyp

    integer

    Måttenheter
    • mg/dl
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0014792
    mg/dl
    Is the erythrocyte measurement value within normal range?
    Beskrivning

    Blood cell count: erythrocyte measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0014792
    Are findings in erythrocyte measurement clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: erythrocyte measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0014792
    Leukocyte measurement value
    Beskrivning

    Blood cell count: leukocyte measurement

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0023516
    U/l
    Is the leukocyte measurement value within normal range?
    Beskrivning

    Blood cell count: leukocyte measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0023516
    Are findings in Leukocyte measurement clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count:Leukocyte measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0023516
    Absolute neutrophils count measurement value
    Beskrivning

    Blood cell count: Neutrophils count

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0948762
    U/l
    Is the count of neutrophils within normal range?
    Beskrivning

    Blood cell count:neutrophils count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0948762
    Are findings in neutrophils count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count:neutrophils count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0948762
    Lymphocyte count measurement value
    Beskrivning

    Blood cell count:lymphocyte count

    Datatyp

    integer

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200635
    U/l
    Is the count of lymphocytes within normal range?
    Beskrivning

    Blood cell count:lymphocyte count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200635
    Are findings in lymphocyte count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count:lymphocyte count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200635
    Monocyte measurement value
    Beskrivning

    Blood cell count: Monocyte count

    Datatyp

    integer

    Måttenheter
    • g/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0750880
    g/l
    Is the monocyte measurement value within normal range?
    Beskrivning

    Blood cell count: Monocyte count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0750880
    Are findings in monocyte count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: Monocyte count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0750880
    Eosinophils measurement value
    Beskrivning

    Blood cell count: Eosinophils count

    Datatyp

    integer

    Måttenheter
    • g/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200638
    g/l
    Is the count of eosinophils within normal range?
    Beskrivning

    Blood cell count: Eosinophils count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200638
    Are findings in eosinophils count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: eosinophils count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200638
    Basophil measurement value
    Beskrivning

    Blood cell count: Basophil count

    Datatyp

    integer

    Måttenheter
    • g/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200641
    g/l
    Is the count of basophils within normal range?
    Beskrivning

    Blood cell count: Basophil count

    Datatyp

    boolean

    Are findings in basophil count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: Basophil count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0200641
    Platelets count measurement value
    Beskrivning

    Blood cell count: platelets count

    Datatyp

    integer

    Måttenheter
    • g/l
    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0032181
    g/l
    Is the platelets count within normal range?
    Beskrivning

    Blood cell count: platelets count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0032181
    Are findings in platelets count clinically significant? If `Yes`, please fill in AE form.
    Beskrivning

    Blood cell count: platelets count

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005771
    UMLS CUI [1,2]
    C0032181
    Urine sample date and time
    Beskrivning

    Urine Sample Date

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200354
    Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
    Beskrivning

    Urine Sample

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0456984
    If urine sample test results are abnormal, please specify
    Beskrivning

    Urine sample test results

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0456984
    Confirmation of correctness
    Beskrivning

    Confirmation of correctness

    Name of Investigator
    Beskrivning

    Name of Investigator

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0008961
    Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
    Beskrivning

    Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519316
    Date of completion of this form
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Tillbaka till toppen

    Similar models

    Case Report Form (HIPEC) Visit 7

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Visit 7:Day 14 post-surgery
    Patient ID
    Item
    Patient ID
    integer
    C1269815 (UMLS CUI [1])
    CRF number
    Item
    CRF number
    integer
    C1516308 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    date
    Item
    Date of visit
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Vital signs, concomitant medication and CTCAE
    Heart rate
    Item
    Heart rate count
    integer
    C0018810 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement
    text
    C0005823 (UMLS CUI [1])
    Body Temperature
    Item
    Body Temperature
    float
    C0005903 (UMLS CUI [1])
    Concomitant agent
    Item
    Has concomitant medication been subject to change? If `Yes` please fill in Concomitant medication form.
    boolean
    C2347852 (UMLS CUI [1])
    CTCAE
    Item
    Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
    boolean
    C1516728 (UMLS CUI [1])
    Item Group
    Laboratory results
    Date of venous blood sampling
    Item
    Date of venous blood sampling
    date
    C0190979 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of laboratory procedure
    Item
    Time of laboratory procedure (according to laboratory sheet)
    time
    C0022885 (UMLS CUI [1])
    Serologic tests Creatinine
    Item
    Creatinine measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0201975 (UMLS CUI [1,2])
    Serologic tests Creatinine
    Item
    Is Creatinine value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201975 (UMLS CUI [1,2])
    Serologic tests Creatinine
    Item
    Are Creatinine measurement findings clinically significant? If `Yes`, please fill in AE- form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201975 (UMLS CUI [1,2])
    Serologic tests Urea measurement
    Item
    Urea measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    Serologic tests Urea measurement
    Item
    Is Urea measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    Serologic tests Urea measurement
    Item
    Are Urea measurement findings clinically significant? If `Yes`, please fill in AE-Form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    Serologic tests Bilirubin measurement
    Item
    Bilirubin measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0344395 (UMLS CUI [1,2])
    Serologic tests Bilirubin measurement
    Item
    Is Bilirubin measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0344395 (UMLS CUI [1,2])
    Serologic tests Bilirubin measurement
    Item
    Are Bilirubin measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0344395 (UMLS CUI [1,2])
    Serologic tests GPT measurement
    Item
    GPT measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    Serologic tests GPT measurement
    Item
    Is GPT value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    Serologic measurement GPT measurement
    Item
    Are GPT measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    Serologic tests GOT measurement
    Item
    GOT measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Serologic tests GOT measurement
    Item
    Is GOT value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Serologic tests GOT measurement
    Item
    Are GOT measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Serologic tests GGT measurement
    Item
    GGT measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0202035 (UMLS CUI [1,2])
    Serologic tests GGT Measurement
    Item
    Is GGT measurement within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0202035 (UMLS CUI [1,2])
    Serologic tests GGT measurement
    Item
    Are GGT measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0202035 (UMLS CUI [1,2])
    Serologic tests Albumin measurement
    Item
    Albumin measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    Serologic tests Albumin measurement
    Item
    Is Albumin measurement within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    Serologic tests Albumin measurement
    Item
    Are Albumin measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    Serologic tests serum potassium
    Item
    Serum potassium measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0302353 (UMLS CUI [1,2])
    Serologic tests serum potassium
    Item
    Is serum potassium measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0302353 (UMLS CUI [1,2])
    Serologic tests serum potassium
    Item
    Are serum potassium measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0302353 (UMLS CUI [1,2])
    Serologic tests serum sodium
    Item
    Serum sodium measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0523891 (UMLS CUI [1,2])
    Serologic tests serum sodium
    Item
    Is serum sodium measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0523891 (UMLS CUI [1,2])
    Serologic tests serum sodium
    Item
    Are serum sodium measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0523891 (UMLS CUI [1,2])
    Serologic tests serum calcium
    Item
    Serum calcium measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C0728876 (UMLS CUI [1,2])
    Serologic tests serum calcium
    Item
    Is serum calcium measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C0728876 (UMLS CUI [1,2])
    Serologic measurement serum calcium
    Item
    Are serum calcium measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C0728876 (UMLS CUI [1,2])
    Serologic tests serum chloride
    Item
    Serum chloride measurement value
    integer
    C0036743 (UMLS CUI [1,1])
    C1317978 (UMLS CUI [1,2])
    Serologic tests serum chloride
    Item
    Is serum chloride measurement value within normal range?
    boolean
    C0036743 (UMLS CUI [1,1])
    C1317978 (UMLS CUI [1,2])
    Serologic tests serum chloride
    Item
    Are serum chloride measurement findings clinically significant? If `Yes` , please fill in AE form.
    boolean
    C0036743 (UMLS CUI [1,1])
    C1317978 (UMLS CUI [1,2])
    Blood cell count: hemoglobin measurement
    Item
    Hemoglobin measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0518015 (UMLS CUI [1,2])
    Blood cell count: hemoglobin measurement
    Item
    Is the hemoglobin measurement value within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0518015 (UMLS CUI [1,2])
    Blood cell count: hemoglobin measurement
    Item
    Are hemoglobin measurement findings clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0518015 (UMLS CUI [1,2])
    Blood cell count hematocrit level
    Item
    Hematocrit level
    integer
    C0005771 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Blood cell count: Hematocrit level
    Item
    Is the hematocrit level within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Blood cell count: Hematocrit level
    Item
    Are findings in hematocrit level clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Blood cell count: erythrocyte measurement
    Item
    Erythrocyte measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0014792 (UMLS CUI [1,2])
    Blood cell count: erythrocyte measurement
    Item
    Is the erythrocyte measurement value within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0014792 (UMLS CUI [1,2])
    Blood cell count: erythrocyte measurement
    Item
    Are findings in erythrocyte measurement clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0014792 (UMLS CUI [1,2])
    Blood cell count: leukocyte measurement
    Item
    Leukocyte measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0023516 (UMLS CUI [1,2])
    Blood cell count: leukocyte measurement
    Item
    Is the leukocyte measurement value within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0023516 (UMLS CUI [1,2])
    Blood cell count:Leukocyte measurement
    Item
    Are findings in Leukocyte measurement clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0023516 (UMLS CUI [1,2])
    Blood cell count: Neutrophils count
    Item
    Absolute neutrophils count measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0948762 (UMLS CUI [1,2])
    Blood cell count:neutrophils count
    Item
    Is the count of neutrophils within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0948762 (UMLS CUI [1,2])
    Blood cell count:neutrophils count
    Item
    Are findings in neutrophils count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0948762 (UMLS CUI [1,2])
    Blood cell count:lymphocyte count
    Item
    Lymphocyte count measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0200635 (UMLS CUI [1,2])
    Blood cell count:lymphocyte count
    Item
    Is the count of lymphocytes within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0200635 (UMLS CUI [1,2])
    Blood cell count:lymphocyte count
    Item
    Are findings in lymphocyte count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0200635 (UMLS CUI [1,2])
    Blood cell count: Monocyte count
    Item
    Monocyte measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0750880 (UMLS CUI [1,2])
    Blood cell count: Monocyte count
    Item
    Is the monocyte measurement value within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0750880 (UMLS CUI [1,2])
    Blood cell count: Monocyte count
    Item
    Are findings in monocyte count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0750880 (UMLS CUI [1,2])
    Blood cell count: Eosinophils count
    Item
    Eosinophils measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    Blood cell count: Eosinophils count
    Item
    Is the count of eosinophils within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    Blood cell count: eosinophils count
    Item
    Are findings in eosinophils count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    Blood cell count: Basophil count
    Item
    Basophil measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    Blood cell count: Basophil count
    Item
    Is the count of basophils within normal range?
    boolean
    Blood cell count: Basophil count
    Item
    Are findings in basophil count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    Blood cell count: platelets count
    Item
    Platelets count measurement value
    integer
    C0005771 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Blood cell count: platelets count
    Item
    Is the platelets count within normal range?
    boolean
    C0005771 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Blood cell count: platelets count
    Item
    Are findings in platelets count clinically significant? If `Yes`, please fill in AE form.
    boolean
    C0005771 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Urine Sample Date
    Item
    Urine sample date and time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    Item
    Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
    text
    C0200354 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Urine Sample
    Code List
    Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
    CL Item
    normal (1)
    CL Item
    abnormal, clinically not significant (2)
    CL Item
    abnormal, clinically significant (3)
    Urine sample test results
    Item
    If urine sample test results are abnormal, please specify
    text
    C0200354 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Item Group
    Confirmation of correctness
    Name of Investigator
    Item
    Name of Investigator
    text
    C0008961 (UMLS CUI [1])
    Signature
    Item
    Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
    text
    C1519316 (UMLS CUI [1])
    Date
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
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