ID

22317

Beschrijving

Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Week 24 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Trefwoorden

Versies (1)
  1. 29-05-17 29-05-17 -
Geüploaded op

29 mei 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572

    Engels

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572

    1 Formulieren  
    Current Medical Conditions / Baseline Signs and Symptoms
    Beschrijving

    Current Medical Conditions / Baseline Signs and Symptoms

    Alias
    UMLS CUI-1
    C3899485
    UMLS CUI-2
    C1457887
    Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
    Beschrijving

    current medical conditions, baseline signs or symptoms

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3899485
    UMLS CUI [1,2]
    C1457887
    Current Medical Conditions or Baseline Signs and symptoms
    Beschrijving

    If YES, record all screening clinical signs and symptoms below according to the instructions on the facing page.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3899485
    UMLS CUI [1,2]
    C1457887
    NCI CTCAE Grade
    Beschrijving

    Refer to the NCI CTCAE Common Toxicity Criteria version 3 in the study reference manual. If the condition is not found in the NCI CTCAE, assign a grade using one of the following: 1=Mild, 2=Moderate, 3=Severe, 4=Life Threatening

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3887242
    Physical Exam (Vital Signs, Weight, Height)
    Beschrijving

    Physical Exam (Vital Signs, Weight, Height)

    Alias
    UMLS CUI-1
    C0518766
    Date Vital Signs
    Beschrijving

    NOTE: Record Vital Signs within 2 weeks prior to first dose of medication NOTE: Blood pressure and heart rate must be taken after 5 minutes of sitting

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blood pressure systolic
    Beschrijving

    Blood pressure systolic

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure diastolic
    Beschrijving

    Blood pressure diastolic

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Height
    Beschrijving

    Height

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Temperature
    Beschrijving

    Temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    ECOG Performance Status
    Beschrijving

    ECOG Performance Status

    Alias
    UMLS CUI-1
    C1520224
    ECOG
    Beschrijving

    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Cardiac Assessments Screening
    Beschrijving

    Cardiac Assessments Screening

    Alias
    UMLS CUI-1
    C1623258
    UMLS CUI-2
    C0013516
    Was a 12-lead ECG performed?
    Beschrijving

    If NO, record details on the INVESTIGATOR COMMENT LOG page. If YES, record details below.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0430456
    Date of assessment
    Beschrijving

    Date of assessment

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1623258
    Check the appropriate box to indicate ECG results.
    Beschrijving

    ECG results

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1623258
    If ABNORMAL, check to indicate if the abnormalities are clinically significant.
    Beschrijving

    If YES, record the abnormality on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page at Screening.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1623258
    Was an Echocardiogram (ECHO) performed?
    Beschrijving

    If YES, record details below.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013516
    Institution name
    Beschrijving

    Institution name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0013516
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013516
    Left ventricular ejection fraction
    Beschrijving

    Left ventricular ejection fraction

    Datatype

    integer

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0013516
    %
    Lower limit of normal
    Beschrijving

    Lower limit of normal

    Datatype

    integer

    Maateenheden
    • %
    Alias
    UMLS CUI [1,1]
    C1518030
    UMLS CUI [1,2]
    C0428772
    UMLS CUI [2]
    C0013516
    %
    Was a Multi-gated acquisition (MUGA) scan performed?
    Beschrijving

    If YES, record details below.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0521317
    Institution name
    Beschrijving

    Institution name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0521317
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0521317
    Left ventricular ejection fraction
    Beschrijving

    Left ventricular ejection fraction

    Datatype

    integer

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0521317
    %
    Lower limit of normal
    Beschrijving

    NOTE: If left ventricular ejection fraction is not within institutional range of normal, the subject must not enter the study.

    Datatype

    integer

    Maateenheden
    • %
    Alias
    UMLS CUI [1,1]
    C1518030
    UMLS CUI [1,2]
    C0428772
    UMLS CUI [2]
    C0521317
    %
    Hematology
    Beschrijving

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Lab ID
    Beschrijving

    Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Lab name
    Beschrijving

    Lab name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1882331
    Date hematology sample taken
    Beschrijving

    Date hematology sample taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [2]
    C0474523
    Units for differential, check one:
    Beschrijving

    Units

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519795
    UMLS CUI [2]
    C0474523
    Hemoglobin
    Beschrijving

    Hemoglobin

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0518015
    Hematocrit
    Beschrijving

    Hematocrit

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0518014
    RBC
    Beschrijving

    RBC

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0014772
    Platelets
    Beschrijving

    Platelets

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0032181
    Total WBC
    Beschrijving

    Total WBC

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophils
    Beschrijving

    Neutrophils

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0948762
    Granulocytes
    Beschrijving

    Granulocytes

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0857490
    Lymphocytes
    Beschrijving

    Lymphocytes

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0200635
    Monocytes
    Beschrijving

    Monocytes

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0200637
    Eosinophils
    Beschrijving

    Eosinophils

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0200638
    Basophils
    Beschrijving

    Basophils

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0200641
    Clinical Chemistry
    Beschrijving

    Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C2347783
    Lab ID
    Beschrijving

    Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Lab name
    Beschrijving

    Lab name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1882331
    Date clinical chemistry sample taken
    Beschrijving

    Date clinical chemistry sample taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [2]
    C0008000
    Sodium
    Beschrijving

    Sodium

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Beschrijving

    Potassium

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0202194
    Chloride
    Beschrijving

    Chloride

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201952
    Bicarbonate
    Beschrijving

    Bicarbonate

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0202059
    Calcium
    Beschrijving

    Calcium

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201925
    Glucose
    Beschrijving

    Glucose

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0202042
    Total Protein
    Beschrijving

    Total Protein

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Beschrijving

    Albumin

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201838
    Uric acid
    Beschrijving

    Uric acid

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0202239
    Creatinine
    Beschrijving

    Creatinine

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201976
    BUN
    Beschrijving

    BUN

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0005845
    Urea
    Beschrijving

    Urea

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0523961
    Total bilirubin
    Beschrijving

    Total bilirubin

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201913
    Alkaline phosphatase
    Beschrijving

    Alkaline phosphatase

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201850
    AST (SGOT)
    Beschrijving

    AST (SGOT)

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201899
    ALT (SGPT)
    Beschrijving

    ALT (SGPT)

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201836
    Calculated Creatinine Clearance
    Beschrijving

    NOTE: Refer to the creatinine clearance worksheet for calculation.

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0373595
    Weight
    Beschrijving

    Creatinine Clearance Worksheet

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Beschrijving

    Creatinine Clearance Worksheet

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Age
    Beschrijving

    Creatinine Clearance Worksheet

    Datatype

    integer

    Maateenheden
    • years
    Alias
    UMLS CUI [1]
    C0001779
    years
    Serum Creatinine
    Beschrijving

    Creatinine Clearance Worksheet

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201976
    Serum Creatinine Units, check one:
    Beschrijving

    Creatinine Clearance Worksheet

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0201976
    UMLS CUI [1,2]
    C1519795
    Response Assessment
    Beschrijving

    Response Assessment

    Alias
    UMLS CUI-1
    C0871261
    Date of lesion evaluation
    Beschrijving

    Response assessments are required at Week 24. If the subject had a complete response or partial response a confirmatory scan should be performed no less than 4 weeks later.

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0220825
    Response assessment, check one:
    Beschrijving

    Response assessment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0221198
    If progressive disease is checked, indicate the primary method of evaluation.
    Beschrijving

    primary method of evaluation

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date of symptomatic progression of cancer
    Beschrijving

    Symptomatic progression of cancer, if checked, complete details below

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0178874
    UMLS CUI [1,2]
    C0011008
    Specify symptoms
    Beschrijving

    Specify symptoms

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1457887
    Confirmatory Scan
    Beschrijving

    Confirmatory Scan

    Date of lesion evaluation
    Beschrijving

    Response assessments are required at Week 24. If the subject had a complete response or partial response a confirmatory scan should be performed no less than 4 weeks later.

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0220825
    Response assessment, check one:
    Beschrijving

    Response assessment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0221198
    If progressive disease is checked, indicate the primary method of evaluation.
    Beschrijving

    primary method of evaluation

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date of symptomatic progression of cancer
    Beschrijving

    Symptomatic progression of cancer, if checked, complete details below

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0178874
    UMLS CUI [1,2]
    C0011008
    Specify symptoms
    Beschrijving

    Specify symptoms

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1457887
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    Similar models

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Current Medical Conditions / Baseline Signs and Symptoms
    C3899485 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    Item
    Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
    text
    C3899485 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    signed informed consent
    Code List
    Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Current Medical Conditions or Baseline Signs and symptoms
    Item
    Current Medical Conditions or Baseline Signs and symptoms
    text
    C3899485 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Item
    NCI CTCAE Grade
    integer
    C3887242 (UMLS CUI [1])
    NCI CTCAE Grade
    Code List
    NCI CTCAE Grade
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Life Threatening (4)
    Item Group
    Physical Exam (Vital Signs, Weight, Height)
    C0518766 (UMLS CUI-1)
    Date Vital Signs
    Item
    Date Vital Signs
    date
    C0011008 (UMLS CUI [1])
    Blood pressure systolic
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure diastolic
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    ECOG Performance Status
    C1520224 (UMLS CUI-1)
    ECOG
    Item
    ECOG
    integer
    C1520224 (UMLS CUI [1])
    Item Group
    Cardiac Assessments Screening
    C1623258 (UMLS CUI-1)
    C0013516 (UMLS CUI-2)
    Item
    Was a 12-lead ECG performed?
    text
    C0430456 (UMLS CUI [1])
    signed informed consent
    Code List
    Was a 12-lead ECG performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of assessment
    Item
    Date of assessment
    date
    C0011008 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    Item
    Check the appropriate box to indicate ECG results.
    text
    C1623258 (UMLS CUI [1])
    ECG results
    Code List
    Check the appropriate box to indicate ECG results.
    CL Item
    Normal (N)
    CL Item
    Abnormal (A)
    Item
    If ABNORMAL, check to indicate if the abnormalities are clinically significant.
    text
    C1623258 (UMLS CUI [1])
    signed informed consent
    Code List
    If ABNORMAL, check to indicate if the abnormalities are clinically significant.
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was an Echocardiogram (ECHO) performed?
    text
    C0013516 (UMLS CUI [1])
    signed informed consent
    Code List
    Was an Echocardiogram (ECHO) performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Institution name
    Item
    Institution name
    text
    C1301943 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Left ventricular ejection fraction
    Item
    Left ventricular ejection fraction
    integer
    C0428772 (UMLS CUI [1])
    C0013516 (UMLS CUI [2])
    Lower limit of normal
    Item
    Lower limit of normal
    integer
    C1518030 (UMLS CUI [1,1])
    C0428772 (UMLS CUI [1,2])
    C0013516 (UMLS CUI [2])
    Item
    Was a Multi-gated acquisition (MUGA) scan performed?
    text
    C0521317 (UMLS CUI [1])
    signed informed consent
    Code List
    Was a Multi-gated acquisition (MUGA) scan performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Institution name
    Item
    Institution name
    text
    C1301943 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    Left ventricular ejection fraction
    Item
    Left ventricular ejection fraction
    integer
    C0428772 (UMLS CUI [1])
    C0521317 (UMLS CUI [2])
    Lower limit of normal
    Item
    Lower limit of normal
    integer
    C1518030 (UMLS CUI [1,1])
    C0428772 (UMLS CUI [1,2])
    C0521317 (UMLS CUI [2])
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Lab ID
    Item
    Lab ID
    integer
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Lab name
    Item
    Lab name
    text
    C1882331 (UMLS CUI [1])
    Date hematology sample taken
    Item
    Date hematology sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0474523 (UMLS CUI [2])
    Item
    Units for differential, check one:
    integer
    C1519795 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    Units
    Code List
    Units for differential, check one:
    CL Item
    Percent % (1)
    CL Item
    Absolute Count (2)
    Hemoglobin
    Item
    Hemoglobin
    float
    C0518015 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    RBC
    Item
    RBC
    integer
    C0014772 (UMLS CUI [1])
    Platelets
    Item
    Platelets
    integer
    C0032181 (UMLS CUI [1])
    Total WBC
    Item
    Total WBC
    integer
    C0023508 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    integer
    C0948762 (UMLS CUI [1])
    Granulocytes
    Item
    Granulocytes
    integer
    C0857490 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    integer
    C0200635 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes
    integer
    C0200637 (UMLS CUI [1])
    Eosinophils
    Item
    Eosinophils
    integer
    C0200638 (UMLS CUI [1])
    Basophils
    Item
    Basophils
    integer
    C0200641 (UMLS CUI [1])
    Item Group
    Clinical Chemistry
    C0008000 (UMLS CUI-1)
    C2347783 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    integer
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Lab name
    Item
    Lab name
    text
    C1882331 (UMLS CUI [1])
    Date clinical chemistry sample taken
    Item
    Date clinical chemistry sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0008000 (UMLS CUI [2])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Chloride
    Item
    Chloride
    float
    C0201952 (UMLS CUI [1])
    Bicarbonate
    Item
    Bicarbonate
    float
    C0202059 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    Total Protein
    Item
    Total Protein
    float
    C0555903 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    Uric acid
    Item
    Uric acid
    float
    C0202239 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    BUN
    Item
    BUN
    float
    C0005845 (UMLS CUI [1])
    Urea
    Item
    Urea
    float
    C0523961 (UMLS CUI [1])
    Total bilirubin
    Item
    Total bilirubin
    float
    C0201913 (UMLS CUI [1])
    Alkaline phosphatase
    Item
    Alkaline phosphatase
    float
    C0201850 (UMLS CUI [1])
    AST (SGOT)
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    ALT (SGPT)
    Item
    ALT (SGPT)
    float
    C0201836 (UMLS CUI [1])
    Calculated Creatinine Clearance
    Item
    Calculated Creatinine Clearance
    float
    C0373595 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI [1])
    Serum Creatinine
    Item
    Serum Creatinine
    float
    C0201976 (UMLS CUI [1])
    Item
    Serum Creatinine Units, check one:
    integer
    C0201976 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Serum Creatinine Units
    Code List
    Serum Creatinine Units, check one:
    CL Item
    mg/dL (1)
    CL Item
    μmol/L (2)
    Item Group
    Response Assessment
    C0871261 (UMLS CUI-1)
    Date of lesion evaluation
    Item
    Date of lesion evaluation
    date
    C0221198 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    Item
    Response assessment, check one:
    text
    C0521982 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Response assessment
    Code List
    Response assessment, check one:
    CL Item
    Complete response (CR)
    CL Item
    Partial response (PR)
    CL Item
    Stable disease (SD)
    CL Item
    Progressive disease (PD)
    CL Item
    Unknown (U)
    Item
    If progressive disease is checked, indicate the primary method of evaluation.
    text
    C2911685 (UMLS CUI [1])
    primary method of evaluation
    Code List
    If progressive disease is checked, indicate the primary method of evaluation.
    CL Item
    Progressive disease by lesion evaluation (PLE)
    CL Item
    Symptomatic progression of cancer (SPC)
    Date of symptomatic progression of cancer
    Item
    Date of symptomatic progression of cancer
    date
    C0178874 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Specify symptoms
    Item
    Specify symptoms
    text
    C1457887 (UMLS CUI [1])
    Item Group
    Confirmatory Scan
    Date of lesion evaluation
    Item
    Date of lesion evaluation
    date
    C0221198 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    Item
    Response assessment, check one:
    text
    C0521982 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Response assessment
    Code List
    Response assessment, check one:
    CL Item
    Complete response (CR)
    CL Item
    Partial response (PR)
    CL Item
    Stable disease (SD)
    CL Item
    Progressive disease (PD)
    CL Item
    Unknown (U)
    Item
    If progressive disease is checked, indicate the primary method of evaluation.
    text
    C2911685 (UMLS CUI [1])
    primary method of evaluation
    Code List
    If progressive disease is checked, indicate the primary method of evaluation.
    CL Item
    Progressive disease by lesion evaluation (PLE)
    CL Item
    Symptomatic progression of cancer (SPC)
    Date of symptomatic progression of cancer
    Item
    Date of symptomatic progression of cancer
    date
    C0178874 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Specify symptoms
    Item
    Specify symptoms
    text
    C1457887 (UMLS CUI [1])
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