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ID

22073

Beschreibung

XELODA and Lapatinib Advanced or Metastatic Breast Cancer 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: Withdrawal / Study Conclusion 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

Stichworte

Versionen (2)
  1. 18.05.17 18.05.17 -
  2. 18.05.17 18.05.17 -
Hochgeladen am

18. Mai 2017

DOI

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    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

    Englisch

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

    1 Formulare  
    Withdrawal / Study Conclusion
    Beschreibung

    Withdrawal / Study Conclusion

    Alias
    UMLS CUI-1
    C2349954
    UMLS CUI-2
    C1707478
    UMLS CUI-3
    C0008976
    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)?
    Beschreibung

    current medical conditions, baseline signs or symptoms

    Datentyp

    text

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

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

    Datentyp

    text

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

    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

    Datentyp

    integer

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

    Physical Exam (Vital Signs, Weight, Height)

    Alias
    UMLS CUI-1
    C0518766
    Date Vital Signs
    Beschreibung

    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

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blood pressure systolic
    Beschreibung

    Blood pressure systolic

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure diastolic
    Beschreibung

    Blood pressure diastolic

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Height
    Beschreibung

    Height

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschreibung

    Weight

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Temperature
    Beschreibung

    Temperature

    Datentyp

    float

    Maßeinheiten
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    ECOG Performance Status
    Beschreibung

    ECOG Performance Status

    Alias
    UMLS CUI-1
    C1520224
    ECOG
    Beschreibung

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

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Cardiac Assessments Screening
    Beschreibung

    Cardiac Assessments Screening

    Alias
    UMLS CUI-1
    C1827871
    UMLS CUI-2
    C1623258
    UMLS CUI-3
    C0013516
    Was a 12-lead ECG performed?
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0430456
    Date of assessment
    Beschreibung

    Date of assessment

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0430456
    Check the appropriate box to indicate ECG results.
    Beschreibung

    ECG results

    Datentyp

    text

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

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

    Datentyp

    text

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

    If YES, record details below.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013516
    Institution name
    Beschreibung

    Institution name

    Datentyp

    text

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

    Date

    Datentyp

    date

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

    Left ventricular ejection fraction

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0013516
    %
    Lower limit of normal
    Beschreibung

    Lower limit of normal

    Datentyp

    integer

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

    If YES, record details below.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0521317
    Institution name
    Beschreibung

    Institution name

    Datentyp

    text

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

    Date

    Datentyp

    date

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

    Left ventricular ejection fraction

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0521317
    %
    Lower limit of normal
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C1518030
    UMLS CUI [1,2]
    C0428772
    UMLS CUI [2]
    C0521317
    %
    Hematology
    Beschreibung

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Lab ID
    Beschreibung

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

    Datentyp

    integer

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

    Lab name

    Datentyp

    text

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

    Date hematology sample taken

    Datentyp

    date

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

    Units

    Datentyp

    integer

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

    Hemoglobin

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0518015
    Hematocrit
    Beschreibung

    Hematocrit

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0518014
    RBC
    Beschreibung

    RBC

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0014772
    Platelets
    Beschreibung

    Platelets

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0032181
    Total WBC
    Beschreibung

    Total WBC

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophils
    Beschreibung

    Neutrophils

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0948762
    Granulocytes
    Beschreibung

    Granulocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0857490
    Lymphocytes
    Beschreibung

    Lymphocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0200635
    Monocytes
    Beschreibung

    Monocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0200637
    Eosinophils
    Beschreibung

    Eosinophils

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0200638
    Basophils
    Beschreibung

    Basophils

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0200641
    Clinical Chemistry
    Beschreibung

    Clinical Chemistry

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

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

    Datentyp

    integer

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

    Lab name

    Datentyp

    text

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

    Date clinical chemistry sample taken

    Datentyp

    date

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

    Sodium

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Beschreibung

    Potassium

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0202194
    Chloride
    Beschreibung

    Chloride

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201952
    Bicarbonate
    Beschreibung

    Bicarbonate

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0202059
    Calcium
    Beschreibung

    Calcium

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201925
    Glucose
    Beschreibung

    Glucose

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0202042
    Total Protein
    Beschreibung

    Total Protein

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Beschreibung

    Albumin

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201838
    Uric acid
    Beschreibung

    Uric acid

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0202239
    Creatinine
    Beschreibung

    Creatinine

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201976
    BUN
    Beschreibung

    BUN

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0005845
    Urea
    Beschreibung

    Urea

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0523961
    Total bilirubin
    Beschreibung

    Total bilirubin

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201913
    Alkaline phosphatase
    Beschreibung

    Alkaline phosphatase

    Datentyp

    float

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

    AST (SGOT)

    Datentyp

    float

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

    ALT (SGPT)

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0201836
    Calculated Creatinine Clearance
    Beschreibung

    NOTE: Refer to the creatinine clearance worksheet for calculation.

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0373595
    Weight
    Beschreibung

    Creatinine Clearance Worksheet

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Beschreibung

    Creatinine Clearance Worksheet

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Age
    Beschreibung

    Creatinine Clearance Worksheet

    Datentyp

    integer

    Maßeinheiten
    • years
    Alias
    UMLS CUI [1]
    C0001779
    years
    Serum Creatinine
    Beschreibung

    Creatinine Clearance Worksheet

    Datentyp

    float

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

    Creatinine Clearance Worksheet

    Datentyp

    integer

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

    Response Assessment

    Alias
    UMLS CUI-1
    C0871261
    UMLS CUI-2
    C0521982
    Date of lesion evaluation
    Beschreibung

    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.

    Datentyp

    date

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

    Response assessment

    Datentyp

    text

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

    primary method of evaluation

    Datentyp

    text

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

    Symptomatic progression of cancer, if checked, complete details below

    Datentyp

    date

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

    Specify symptoms

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1457887
    Confirmatory Scan
    Beschreibung

    Confirmatory Scan

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0750484
    UMLS CUI-3
    C0521982
    Date of lesion evaluation
    Beschreibung

    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.

    Datentyp

    date

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

    Response assessment

    Datentyp

    text

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

    primary method of evaluation

    Datentyp

    text

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

    Symptomatic progression of cancer, if checked, complete details below

    Datentyp

    date

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

    Specify symptoms

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1457887
    Endpoint Evaluation : Investigator
    Beschreibung

    Endpoint Evaluation : Investigator

    Alias
    UMLS CUI-1
    C0220825
    UMLS CUI-2
    C0521982
    Best response, check one:
    Beschreibung

    Best response

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0521982
    Date of response
    Beschreibung

    If partial response or complete response is ✔, complete below:

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0521982
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    Ähnliche Modelle

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Withdrawal / Study Conclusion
    C2349954 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    C0008976 (UMLS CUI-3)
    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
    C1827871 (UMLS CUI-1)
    C1623258 (UMLS CUI-2)
    C0013516 (UMLS CUI-3)
    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])
    C0430456 (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)
    C0521982 (UMLS CUI-2)
    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
    C0011923 (UMLS CUI-1)
    C0750484 (UMLS CUI-2)
    C0521982 (UMLS CUI-3)
    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
    Endpoint Evaluation : Investigator
    C0220825 (UMLS CUI-1)
    C0521982 (UMLS CUI-2)
    Item
    Best response, check one:
    text
    C0521982 (UMLS CUI [1])
    Response assessment
    Code List
    Best response, 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)
    Date of response
    Item
    Date of response
    date
    C0011008 (UMLS CUI [1,1])
    C0521982 (UMLS CUI [1,2])
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