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ID

41456

Beschreibung

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Stichworte

Versionen (1)
  1. 13.10.20 13.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Oktober 2020

DOI

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Lizenz

Creative Commons BY 4.0
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    Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

    Englisch

    Cycle 1 - Day 15

    1 Formulare  
    1. StudyEvent: ODM
      1. Cycle 1 - Day 15
    Date of Visit/Assessment
    Beschreibung

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Beschreibung

    Date of visit; Assessment Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Central/Local Lab
    Beschreibung

    Central/Local Lab

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C1880016
    UMLS CUI-3
    C0022885
    UMLS CUI-4
    C0205276
    Was a central laboratory used?
    Beschreibung

    Central Laboratory

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1880016
    Was a local lab used for Chemistry assessments?
    Beschreibung

    Chemistry, Clinical, Laboratory, Local

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0205276
    Was a local lab used for Hematology assessments?
    Beschreibung

    Hematology finding, Laboratory, Local

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0205276
    Local Laboratory - Clinical Chemistry
    Beschreibung

    Local Laboratory - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Laboratory ID
    Beschreibung

    Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C2986056
    Laboratory Used For This Sample
    Beschreibung

    Laboratory Procedures, Chemistry, Clinical, Laboratory

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0022877
    Date sample taken
    Beschreibung

    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    ALT
    Beschreibung

    Laboratory Procedures, Alanine aminotransferase measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C1274040
    ALT - Results
    Beschreibung

    Laboratory Procedures, Alanine aminotransferase measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C1274040
    ALT - Units
    Beschreibung

    Laboratory Procedures, Alanine aminotransferase measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    ALT - Low
    Beschreibung

    Laboratory Procedures, Alanine aminotransferase measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    ALT - High
    Beschreibung

    Laboratory Procedures, Alanine aminotransferase measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    AST
    Beschreibung

    Laboratory Procedures, Aspartate aminotransferase measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201899
    AST - Results
    Beschreibung

    Laboratory Procedures, Aspartate aminotransferase measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201899
    UMLS CUI [1,3]
    C1274040
    AST - Units
    Beschreibung

    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201899
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    AST - Low
    Beschreibung

    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201899
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    AST - High
    Beschreibung

    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201899
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Total Bilirubin
    Beschreibung

    Laboratory Procedures, Bilirubin, total measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201913
    Total Bilirubin - Results
    Beschreibung

    Laboratory Procedures, Bilirubin, total measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201913
    UMLS CUI [1,3]
    C1274040
    Total Bilirubin - Units
    Beschreibung

    Laboratory Procedures, Bilirubin, total measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201913
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Total Bilirubin - Low
    Beschreibung

    Laboratory Procedures, Bilirubin, total measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201913
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Total Bilirubin - High
    Beschreibung

    Laboratory Procedures, Bilirubin, total measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201913
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Glucose
    Beschreibung

    Laboratory Procedures, Glucose measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337438
    Glucose - Results
    Beschreibung

    Laboratory Procedures, Glucose measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337438
    UMLS CUI [1,3]
    C1274040
    Glucose - Units
    Beschreibung

    Laboratory Procedures, Glucose measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337438
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Glucose - High
    Beschreibung

    Laboratory Procedures, Glucose measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337438
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Total Protein
    Beschreibung

    Laboratory Procedures, Total protein measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0555903
    Total Protein - Units
    Beschreibung

    Laboratory Procedures, Total protein measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0555903
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Total Protein - Low
    Beschreibung

    Laboratory Procedures, Total protein measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0555903
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Total Protein - High
    Beschreibung

    Laboratory Procedures, Total protein measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0555903
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Potassium
    Beschreibung

    Laboratory Procedures, Potassium measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0202194
    Potassium - Results
    Beschreibung

    Laboratory Procedures, Potassium measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0202194
    UMLS CUI [1,3]
    C1274040
    Potassium - Units
    Beschreibung

    Laboratory Procedures, Potassium measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0202194
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Potassium - Low
    Beschreibung

    Laboratory Procedures, Potassium measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0202194
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Potassium - High
    Beschreibung

    Laboratory Procedures, Potassium measurement, Result, Upper Limit of Reference Range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0202194
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Sodium
    Beschreibung

    Laboratory Procedures, Sodium measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337443
    Sodium - Results
    Beschreibung

    Laboratory Procedures, Sodium measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337443
    UMLS CUI [1,3]
    C1274040
    Sodium - Units
    Beschreibung

    Laboratory Procedures, Sodium measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337443
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Sodium - Low
    Beschreibung

    Laboratory Procedures, Sodium measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337443
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Sodium - High
    Beschreibung

    Laboratory Procedures, Sodium measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0337443
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Calcium
    Beschreibung

    Laboratory Procedures, Calcium measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201925
    Calcium - Results
    Beschreibung

    Laboratory Procedures, Calcium measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201925
    UMLS CUI [1,3]
    C1274040
    Calcium - Units
    Beschreibung

    Laboratory Procedures, Calcium measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201925
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Calcium - Low
    Beschreibung

    Laboratory Procedures, Calcium measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201925
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Calcium - High
    Beschreibung

    Laboratory Procedures, Calcium measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201925
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Alkaline Phosphatase
    Beschreibung

    Laboratory Procedures, Alkaline phosphatase measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201850
    Alkaline Phosphatase - Results
    Beschreibung

    Laboratory Procedures, Alkaline phosphatase measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201850
    UMLS CUI [1,3]
    C1274040
    Alkaline Phosphatase - Units
    Beschreibung

    Laboratory Procedures, Alkaline phosphatase measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201850
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Alkaline Phosphatase - Low
    Beschreibung

    Laboratory Procedures, Alkaline phosphatase measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201850
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Alkaline Phosphatase - High
    Beschreibung

    Laboratory Procedures, Alkaline phosphatase measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201850
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    BUN
    Beschreibung

    Laboratory Procedures, Blood urea nitrogen measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005845
    BUN - Results
    Beschreibung

    Laboratory Procedures, Blood urea nitrogen measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005845
    UMLS CUI [1,3]
    C1274040
    BUN - High
    Beschreibung

    Laboratory Procedures, Blood urea nitrogen measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005845
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Urea
    Beschreibung

    Laboratory Procedures, Urea measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0523961
    Urea - Results
    Beschreibung

    Laboratory Procedures, Urea measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0523961
    UMLS CUI [1,3]
    C1274040
    Urea - Units
    Beschreibung

    Laboratory Procedures, Urea measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0523961
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Urea - Low
    Beschreibung

    Laboratory Procedures, Urea measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0523961
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Urea - High
    Beschreibung

    Laboratory Procedures, Urea measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0523961
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Albumin
    Beschreibung

    Laboratory Procedures, Albumin measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201838
    Albumin - Results
    Beschreibung

    Laboratory Procedures, Albumin measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201838
    UMLS CUI [1,3]
    C1274040
    Albumin - Units
    Beschreibung

    Laboratory Procedures, Albumin measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201838
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Albumin - Low
    Beschreibung

    Laboratory Procedures, Albumin measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201838
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Albumin - High
    Beschreibung

    Laboratory Procedures, Albumin measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201838
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Creatinine
    Beschreibung

    Laboratory Procedures, Creatinine measurement, serum

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201976
    Creatinine - Results
    Beschreibung

    Laboratory Procedures, Creatinine measurement, serum, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201976
    UMLS CUI [1,3]
    C1274040
    Creatinine - Units
    Beschreibung

    Laboratory Procedures, Creatinine measurement, serum, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201976
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Creatinine - Low
    Beschreibung

    Laboratory Procedures, Creatinine measurement, serum, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201976
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Creatinine - High
    Beschreibung

    Laboratory Procedures, Creatinine measurement, serum, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0201976
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Creatinine Clearance
    Beschreibung

    Laboratory Procedures, Creatinine clearance measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0373595
    Creatinine Clearance - Results
    Beschreibung

    Laboratory Procedures, Creatinine clearance measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0373595
    UMLS CUI [1,3]
    C1274040
    Creatinine Clearance - Units
    Beschreibung

    Laboratory Procedures, Creatinine clearance measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0373595
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Creatinine Clearance - Low
    Beschreibung

    Laboratory Procedures, Creatinine clearance measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0373595
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Creatinine Clearance - High
    Beschreibung

    Laboratory Procedures, Creatinine clearance measurement, Result, Upper Limit of Normal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0373595
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519815
    Local Laboratory - Hematology
    Beschreibung

    Local Laboratory - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Laboratory ID
    Beschreibung

    Laboratory Procedures, Hematology finding, Laboratory Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C2986056
    Laboratory Used For This Sample
    Beschreibung

    Laboratory Procedures, Hematology finding, Laboratory

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0022877
    Date sample taken
    Beschreibung

    Laboratory Procedures, Hematology finding, Sampling, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    WBC
    Beschreibung

    Laboratory Procedures, White Blood Cell Count procedure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0023508
    WBC - Results
    Beschreibung

    Laboratory Procedures, White Blood Cell Count procedure, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0023508
    UMLS CUI [1,3]
    C1274040
    WBC - Units
    Beschreibung

    Laboratory Procedures, White Blood Cell Count procedure, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0023508
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    WBC - Low
    Beschreibung

    Laboratory Procedures, White Blood Cell Count procedure, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0023508
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    RBC
    Beschreibung

    Laboratory Procedures, Red Blood Cell Count measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0014772
    RBC - Results
    Beschreibung

    Laboratory Procedures, Red Blood Cell Count measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0014772
    UMLS CUI [1,3]
    C1274040
    RBC - Units
    Beschreibung

    Laboratory Procedures, Red Blood Cell Count measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0014772
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    RBC - Low
    Beschreibung

    Laboratory Procedures, Red Blood Cell Count measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0014772
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Haemoglobin
    Beschreibung

    Laboratory Procedures, Hemoglobin

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0019046
    Haemoglobin - Results
    Beschreibung

    Laboratory Procedures, Hemoglobin, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0019046
    UMLS CUI [1,3]
    C1274040
    Haemoglobin - Units
    Beschreibung

    Laboratory Procedures, Hemoglobin, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0019046
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Haemoglobin - Low
    Beschreibung

    Laboratory Procedures, Hemoglobin, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0019046
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Haematocrit
    Beschreibung

    Laboratory Procedures, Hemoglobin level

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0518014
    Haematocrit - Results
    Beschreibung

    Laboratory Procedures, Hemoglobin level, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0518014
    UMLS CUI [1,3]
    C1274040
    Haematocrit - Units
    Beschreibung

    Laboratory Procedures, Hemoglobin level, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0518014
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Haematocrit - Low
    Beschreibung

    Laboratory Procedures, Hemoglobin level, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0518014
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Lymphocytes
    Beschreibung

    Laboratory Procedures, Lymphocyte

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0024264
    Lymphocytes - Results
    Beschreibung

    Laboratory Procedures, Lymphocyte, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0024264
    UMLS CUI [1,3]
    C1274040
    Lymphocytes - Units
    Beschreibung

    Laboratory Procedures, Lymphocyte, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0024264
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Lymphocytes - Low
    Beschreibung

    Laboratory Procedures, Lymphocyte, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0024264
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Units for Lymphocytes
    Beschreibung

    Laboratory Procedures, Lymphocyte, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0024264
    UMLS CUI [1,3]
    C1519795
    Monocytes
    Beschreibung

    Laboratory Procedures, Monocytes

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0026473
    Monocytes - Results
    Beschreibung

    Laboratory Procedures, Monocytes, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0026473
    UMLS CUI [1,3]
    C1274040
    Monocytes - Units
    Beschreibung

    Laboratory Procedures, Monocytes, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0026473
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Monocytes - Low
    Beschreibung

    Laboratory Procedures, Monocytes, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0026473
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Units for Monocytes
    Beschreibung

    Laboratory Procedures, Monocytes, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0026473
    UMLS CUI [1,3]
    C1519795
    Eosinophils
    Beschreibung

    Laboratory Procedures, Eosinophil count procedure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200638
    Eosinophils - Results
    Beschreibung

    Laboratory Procedures, Eosinophil count procedure, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200638
    UMLS CUI [1,3]
    C1274040
    Eosinophils - Units
    Beschreibung

    Laboratory Procedures, Eosinophil count procedure, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200638
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Eosinophils - Low
    Beschreibung

    Laboratory Procedures, Eosinophil count procedure, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200638
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Unit of Eosinophils
    Beschreibung

    Laboratory Procedures, Eosinophil count procedure, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200638
    UMLS CUI [1,3]
    C1519795
    Basophils
    Beschreibung

    Laboratory Procedures, Blood basophil count (lab test)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200641
    Basophils - Results
    Beschreibung

    Laboratory Procedures, Blood basophil count (lab test), Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200641
    UMLS CUI [1,3]
    C1274040
    Basophils - Units
    Beschreibung

    Laboratory Procedures, Blood basophil count (lab test), Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200641
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Basophils - Low
    Beschreibung

    Laboratory Procedures, Blood basophil count (lab test), Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200641
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Units for Basophils
    Beschreibung

    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200641
    UMLS CUI [1,3]
    C1519795
    Platelets
    Beschreibung

    Laboratory Procedures, Platelet Count measurement

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032181
    Platelets - Results
    Beschreibung

    Laboratory Procedures, Platelet Count measurement, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032181
    UMLS CUI [1,3]
    C1274040
    Platelets - Units
    Beschreibung

    Laboratory Procedures, Platelet Count measurement, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032181
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Platelets - Low
    Beschreibung

    Laboratory Procedures, Platelet Count measurement, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032181
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Total Neutrophils
    Beschreibung

    Laboratory Procedures, Neutrophil count

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200633
    Total Neutrophils - Results
    Beschreibung

    Laboratory Procedures, Neutrophil count, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200633
    UMLS CUI [1,3]
    C1274040
    Total Neutrophils - Units
    Beschreibung

    Laboratory Procedures, Neutrophil count, Result, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200633
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1519795
    Total Neutrophils - Low
    Beschreibung

    Laboratory Procedures, Neutrophil count, Result, Lower limit of reference range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200633
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C1272773
    Units for Neutrophils
    Beschreibung

    Laboratory Procedures, Neutrophil count, Unit of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0200633
    UMLS CUI [1,3]
    C1519795
    Central Lab Data
    Beschreibung

    Central Lab Data

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C1511726
    Hematology Date sample taken
    Beschreibung

    Central Laboratory, Hematology finding, Sampling, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Not Done
    Beschreibung

    Central Laboratory, Hematology finding, Sampling, Not Done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C1272696
    Clinical Chemistry Date sample taken
    Beschreibung

    Central Laboratory, Chemistry, Clinical, Sampling, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Not Done
    Beschreibung

    Central Laboratory, Chemistry, Clinical, Sampling, Not Done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C1272696
    Haem Lab type code
    Beschreibung

    Central Laboratory, Hematology finding, Laboratory, Code

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0022877
    UMLS CUI [1,4]
    C0805701
    Chem Lab type code
    Beschreibung

    Central Laboratory, Chemistry, Clinical, Laboratory, Code

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0022877
    UMLS CUI [1,4]
    C0805701
    Significant Medial/Surgery Questions
    Beschreibung

    Significant Medial/Surgery Questions

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0543467
    Does the subject have any past or current Significant Medical Conditions related to disease under study?
    Beschreibung

    Disease, Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0750502
    Does the subject have any past or current Surgery related to disease under study?
    Beschreibung

    Operative Surgical Procedures

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0543467
    Does the subject have any prior non-CNS radio therapy related to disease under study?
    Beschreibung

    Therapeutic radiology procedure, Previous

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0205156
    Vital Signs
    Beschreibung

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date
    Beschreibung

    Vital signs, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Weight
    Beschreibung

    Body Weight

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Beschreibung

    Body Surface Area

    Datentyp

    float

    Maßeinheiten
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Blood pressure - Systolic
    Beschreibung

    Systolic Pressure

    Datentyp

    integer

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

    Diastolic blood pressure

    Datentyp

    integer

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

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature
    Beschreibung

    Body Temperature

    Datentyp

    float

    Maßeinheiten
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Investigational Product - IV Topotecan Dosing
    Beschreibung

    Investigational Product - IV Topotecan Dosing

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0146224
    UMLS CUI-3
    C0178602
    Sequence number
    Beschreibung

    Experimental drug, Topotecan, Sequence Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C2348184
    Investigational Product
    Beschreibung

    Experimental drug, Topotecan

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    Infusion Start Date
    Beschreibung

    Experimental drug, Topotecan, Infusion procedures, Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C0574032
    UMLS CUI [1,4]
    C0808070
    Scheduled Dose
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Scheduled - procedure status

    Datentyp

    float

    Maßeinheiten
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C0205539
    mg/m2
    Dose Units
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Units of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C1519795
    Actual Dose
    Beschreibung

    Experimental drug, Topotecan, Medication dose

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    mg
    Dose Units
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Units of Measure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C1519795
    Was dose delayed?
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Deferred

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C0205421
    Yes, check all that apply
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Deferred

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C0205421
    Other, specify
    Beschreibung

    Experimental drug, Topotecan, Medication dose, Deferred

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C0205421
    Was dose reduced?
    Beschreibung

    Experimental drug, Topotecan, Dose Reduced

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C1707814
    Yes, check all that apply
    Beschreibung

    Experimental drug, Topotecan, Dose Reduced

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C1707814
    Other, specify
    Beschreibung

    Experimental drug, Topotecan, Dose Reduced

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C1707814
    Treatment Confirmation
    Beschreibung

    Treatment Confirmation

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0750484
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschreibung

    Therapeutic procedure, Correct

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2349182
    No, record reason(s)
    Beschreibung

    Therapeutic procedure, Wrong, Reason and justification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3827420
    UMLS CUI [1,3]
    C0566251
    Lapatinib Compliance
    Beschreibung

    Lapatinib Compliance

    Alias
    UMLS CUI-1
    C1506770
    UMLS CUI-2
    C1321605
    Date Dispensed
    Beschreibung

    Lapatinib, Dispensing medication, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1506770
    UMLS CUI [1,2]
    C0947323
    UMLS CUI [1,3]
    C0011008
    Total Number of Tablets Dispensed
    Beschreibung

    Lapatinib, Dispensed Amount, Tablet Dosage Form

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1506770
    UMLS CUI [1,2]
    C0805077
    UMLS CUI [1,3]
    C0039225
    Date Returned
    Beschreibung

    Lapatinib, Dispensing medication, Return to, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1506770
    UMLS CUI [1,2]
    C0947323
    UMLS CUI [1,3]
    C0332156
    UMLS CUI [1,4]
    C0723001
    UMLS CUI [1,5]
    C0011008
    Total Number of Tablets Returned
    Beschreibung

    Lapatinib, Returned Amount, Tablet Dosage Form

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1506770
    UMLS CUI [1,2]
    C2699071
    UMLS CUI [1,3]
    C0039225
    Continue in This Arm?
    Beschreibung

    Continue in This Arm?

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C2603343
    Will subject continue in current arm?
    Beschreibung

    Continuation status, Clinical Trials

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
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    Ähnliche Modelle

    Cycle 1 - Day 15

    1 Formulare
    1. StudyEvent: ODM
      1. Cycle 1 - Day 15
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit; Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    Central/Local Lab
    C0022885 (UMLS CUI-1)
    C1880016 (UMLS CUI-2)
    C0022885 (UMLS CUI-3)
    C0205276 (UMLS CUI-4)
    Central Laboratory
    Item
    Was a central laboratory used?
    boolean
    C1880016 (UMLS CUI [1])
    Chemistry, Clinical, Laboratory, Local
    Item
    Was a local lab used for Chemistry assessments?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    Hematology finding, Laboratory, Local
    Item
    Was a local lab used for Hematology assessments?
    boolean
    C0474523 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    Item Group
    Local Laboratory - Clinical Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier
    Item
    Laboratory ID
    integer
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C2986056 (UMLS CUI [1,3])
    Item
    Laboratory Used For This Sample
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Laboratory Procedures, Chemistry, Clinical, Laboratory
    Code List
    Laboratory Used For This Sample
    CL Item
    Laboratory 1 (1)
    CL Item
    Laboratory 2 (2)
    CL Item
    Laboratory 3 (3)
    CL Item
    Laboratory 4 (4)
    CL Item
    Laboratory 5 (5)
    CL Item
    Laboratory 6 (6)
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    ALT
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alanine aminotransferase measurement, Result
    Code List
    ALT
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    ALT - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alanine aminotransferase measurement, Result
    Code List
    ALT - Results
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Unit of Measure
    Item
    ALT - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Lower limit of reference range
    Item
    ALT - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Upper Limit of Normal
    Item
    ALT - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    AST
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Laboratory Procedures, Aspartate aminotransferase measurement
    Code List
    AST
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    AST - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Aspartate aminotransferase measurement
    Code List
    AST - Results
    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Unit of Measure
    Item
    AST - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Item
    AST - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Aspartate aminotransferase measurement
    Code List
    AST - Low
    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Upper Limit of Normal
    Item
    AST - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Total Bilirubin
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    Laboratory Procedures, Aspartate aminotransferase measurement
    Code List
    Total Bilirubin
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Bilirubin, total measurement, Result
    Item
    Total Bilirubin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Bilirubin, total measurement, Result, Unit of Measure
    Item
    Total Bilirubin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Bilirubin, total measurement, Result, Lower limit of reference range
    Item
    Total Bilirubin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Bilirubin, total measurement, Result, Upper Limit of Normal
    Item
    Total Bilirubin - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Glucose
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    Laboratory Procedures, Glucose measurement
    Code List
    Glucose
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Glucose measurement, Result
    Item
    Glucose - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Glucose measurement, Result, Unit of Measure
    Item
    Glucose - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Glucose measurement, Result, Upper Limit of Normal
    Item
    Glucose - High
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Total Protein
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    Laboratory Procedures, Total protein measurement
    Code List
    Total Protein
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Total protein measurement, Result, Unit of Measure
    Item
    Total Protein - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Total protein measurement, Result, Lower limit of reference range
    Item
    Total Protein - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Total protein measurement, Result, Upper Limit of Normal
    Item
    Total Protein - High
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Potassium
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    Laboratory Procedures, Total protein measurement
    Code List
    Potassium
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Potassium measurement, Result
    Item
    Potassium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Potassium measurement, Result, Unit of Measure
    Item
    Potassium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Potassium measurement, Result, Lower limit of reference range
    Item
    Potassium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Potassium measurement, Result, Upper Limit of Reference Range
    Item
    Potassium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Sodium
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    Laboratory Procedures, Total protein measurement
    Code List
    Sodium
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Sodium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Total protein measurement
    Code List
    Sodium - Results
    Laboratory Procedures, Sodium measurement, Result, Unit of Measure
    Item
    Sodium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Sodium measurement, Result, Lower limit of reference range
    Item
    Sodium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Sodium measurement, Result, Upper Limit of Normal
    Item
    Sodium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Calcium
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    Laboratory Procedures, Total protein measurement
    Code List
    Calcium
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Calcium measurement, Result
    Item
    Calcium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Calcium measurement, Result, Unit of Measure
    Item
    Calcium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Calcium measurement, Result, Lower limit of reference range
    Item
    Calcium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Calcium measurement, Result, Upper Limit of Normal
    Item
    Calcium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Alkaline Phosphatase
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Alkaline Phosphatase
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Alkaline Phosphatase - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Alkaline Phosphatase - Results
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Unit of Measure
    Item
    Alkaline Phosphatase - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Lower limit of reference range
    Item
    Alkaline Phosphatase - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Upper Limit of Normal
    Item
    Alkaline Phosphatase - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    BUN
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    BUN
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    BUN - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    BUN - Results
    Laboratory Procedures, Blood urea nitrogen measurement, Result, Upper Limit of Normal
    Item
    BUN - High
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Urea
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Urea
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Urea - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Urea - Results
    Laboratory Procedures, Urea measurement, Result, Unit of Measure
    Item
    Urea - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Urea measurement, Result, Lower limit of reference range
    Item
    Urea - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Urea measurement, Result, Upper Limit of Normal
    Item
    Urea - High
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Albumin
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Albumin
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Albumin measurement, Result
    Item
    Albumin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Albumin measurement, Result, Unit of Measure
    Item
    Albumin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Albumin measurement, Result, Lower limit of reference range
    Item
    Albumin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Albumin measurement, Result, Upper Limit of Normal
    Item
    Albumin - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Creatinine
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    Laboratory Procedures, Alkaline phosphatase measurement
    Code List
    Creatinine
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Creatinine measurement, serum, Result
    Item
    Creatinine - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Creatinine measurement, serum, Result, Unit of Measure
    Item
    Creatinine - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine measurement, serum, Result, Lower limit of reference range
    Item
    Creatinine - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine measurement, serum, Result, Upper Limit of Normal
    Item
    Creatinine - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Creatinine Clearance
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    Laboratory Procedures, Creatinine clearance measurement
    Code List
    Creatinine Clearance
    CL Item
    Results (1)
    CL Item
    No results (2)
    Laboratory Procedures, Creatinine clearance measurement, Result
    Item
    Creatinine Clearance - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Item
    Creatinine Clearance - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine clearance measurement
    Code List
    Creatinine Clearance - Units
    Laboratory Procedures, Creatinine clearance measurement, Result, Lower limit of reference range
    Item
    Creatinine Clearance - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Creatinine Clearance - High
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine clearance measurement
    Code List
    Creatinine Clearance - High
    Item Group
    Local Laboratory - Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Laboratory Procedures, Hematology finding, Laboratory Identifier
    Item
    Laboratory ID
    integer
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C2986056 (UMLS CUI [1,3])
    Item
    Laboratory Used For This Sample
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Laboratory Procedures, Chemistry, Clinical, Laboratory
    Code List
    Laboratory Used For This Sample
    CL Item
    Laboratory 1 (1)
    CL Item
    Laboratory 2 (2)
    CL Item
    Laboratory 3 (3)
    CL Item
    Laboratory 4 (4)
    CL Item
    Laboratory 5 (5)
    CL Item
    Laboratory 6 (6)
    Laboratory Procedures, Hematology finding, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    WBC
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    Laboratory Procedures, White Blood Cell Count procedure
    Code List
    WBC
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, White Blood Cell Count procedure, Result
    Item
    WBC - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, White Blood Cell Count procedure, Result, Unit of Measure
    Item
    WBC - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, White Blood Cell Count procedure, Result, Lower limit of reference range
    Item
    WBC - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    RBC
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    Laboratory Procedures, White Blood Cell Count procedure
    Code List
    RBC
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    RBC - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, White Blood Cell Count procedure
    Code List
    RBC - Results
    Laboratory Procedures, Red Blood Cell Count measurement, Result, Unit of Measure
    Item
    RBC - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Red Blood Cell Count measurement, Result, Lower limit of reference range
    Item
    RBC - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Haemoglobin
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    Laboratory Procedures, White Blood Cell Count procedure
    Code List
    Haemoglobin
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Hemoglobin, Result
    Item
    Haemoglobin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Hemoglobin, Result, Unit of Measure
    Item
    Haemoglobin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Hemoglobin, Result, Lower limit of reference range
    Item
    Haemoglobin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Haematocrit
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Laboratory Procedures, Hemoglobin level
    Code List
    Haematocrit
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Hemoglobin level, Result
    Item
    Haematocrit - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Hemoglobin level, Result, Unit of Measure
    Item
    Haematocrit - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Hemoglobin level, Result, Lower limit of reference range
    Item
    Haematocrit - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Lymphocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    Laboratory Procedures, Lymphocyte
    Code List
    Lymphocytes
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Lymphocyte, Result
    Item
    Lymphocytes - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Lymphocyte, Result, Unit of Measure
    Item
    Lymphocytes - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Lymphocyte, Result, Lower limit of reference range
    Item
    Lymphocytes - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Lymphocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Laboratory Procedures, Lymphocyte, Unit of Measure
    Code List
    Units for Lymphocytes
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Monocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    Laboratory Procedures, Monocytes
    Code List
    Monocytes
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Monocytes - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Monocytes
    Code List
    Monocytes - Results
    Laboratory Procedures, Monocytes, Result, Unit of Measure
    Item
    Monocytes - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Monocytes, Result, Lower limit of reference range
    Item
    Monocytes - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Monocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Laboratory Procedures, Monocytes
    Code List
    Units for Monocytes
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Eosinophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    Laboratory Procedures, Monocytes
    Code List
    Eosinophils
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Eosinophil count procedure, Result
    Item
    Eosinophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Eosinophil count procedure, Result, Unit of Measure
    Item
    Eosinophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Eosinophil count procedure, Result, Lower limit of reference range
    Item
    Eosinophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Unit of Eosinophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Laboratory Procedures, Eosinophil count procedure, Unit of Measure
    Code List
    Unit of Eosinophils
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Basophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    Laboratory Procedures, Monocytes
    Code List
    Basophils
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Basophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Monocytes
    Code List
    Basophils - Results
    Laboratory Procedures, Blood basophil count (lab test), Result, Unit of Measure
    Item
    Basophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Blood basophil count (lab test), Result, Lower limit of reference range
    Item
    Basophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Basophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Units for Basophils
    CL Item
    Percent  (1)
    CL Item
    Absolute count (2)
    Item
    Platelets
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Platelets
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Platelets - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Platelets - Results
    Laboratory Procedures, Platelet Count measurement, Result, Unit of Measure
    Item
    Platelets - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Platelet Count measurement, Result, Lower limit of reference range
    Item
    Platelets - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Total Neutrophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Total Neutrophils
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Total Neutrophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Total Neutrophils - Results
    Laboratory Procedures, Neutrophil count, Result, Unit of Measure
    Item
    Total Neutrophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Neutrophil count, Result, Lower limit of reference range
    Item
    Total Neutrophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Neutrophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
    Code List
    Units for Neutrophils
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item Group
    Central Lab Data
    C1880016 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Central Laboratory, Hematology finding, Sampling, Date in time
    Item
    Hematology Date sample taken
    date
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Central Laboratory, Hematology finding, Sampling, Not Done
    Item
    Not Done
    boolean
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Sampling, Date in time
    Item
    Clinical Chemistry Date sample taken
    date
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Sampling, Not Done
    Item
    Not Done
    boolean
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    Central Laboratory, Hematology finding, Laboratory, Code
    Item
    Haem Lab type code
    text
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Laboratory, Code
    Item
    Chem Lab type code
    text
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Item Group
    Significant Medial/Surgery Questions
    C0012634 (UMLS CUI-1)
    C0543467 (UMLS CUI-2)
    Disease, Significant
    Item
    Does the subject have any past or current Significant Medical Conditions related to disease under study?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Operative Surgical Procedures
    Item
    Does the subject have any past or current Surgery related to disease under study?
    boolean
    C0543467 (UMLS CUI [1])
    Therapeutic radiology procedure, Previous
    Item
    Does the subject have any prior non-CNS radio therapy related to disease under study?
    boolean
    C1522449 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital signs, Date in time
    Item
    Actual date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body surface area
    float
    C0005902 (UMLS CUI [1])
    Systolic Pressure
    Item
    Blood pressure - Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure - Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Body Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Investigational Product - IV Topotecan Dosing
    C0304229 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    Item
    Sequence number
    integer
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C2348184 (UMLS CUI [1,3])
    Level of consciousness
    Code List
    Sequence number
    Item
    Investigational Product
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    Level of consciousness
    Code List
    Investigational Product
    CL Item
    Topotecan (1)
    Experimental drug, Topotecan, Infusion procedures, Start Date
    Item
    Infusion Start Date
    date
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C0574032 (UMLS CUI [1,3])
    C0808070 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose, Scheduled - procedure status
    Item
    Scheduled Dose
    float
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C0205539 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose, Units of Measure
    Item
    Dose Units
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose
    Item
    Actual Dose
    float
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    Experimental drug, Topotecan, Medication dose, Units of Measure
    Item
    Dose Units
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose, Deferred
    Item
    Was dose delayed?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C0205421 (UMLS CUI [1,4])
    Item
    Yes, check all that apply
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C0205421 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose, Deferred
    Code List
    Yes, check all that apply
    CL Item
    Neutropenia (1)
    CL Item
    Thrombocytopenia (2)
    CL Item
    Anemia (3)
    CL Item
    Diarrhea (4)
    CL Item
    Nausea and/or Vomiting (5)
    CL Item
    Hand - Foot Syndrome (6)
    CL Item
    Rash (7)
    CL Item
    Other, specify (8)
    Item
    Other, specify
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C0205421 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Medication dose, Deferred
    Code List
    Other, specify
    Experimental drug, Topotecan, Dose Reduced
    Item
    Was dose reduced?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C1707814 (UMLS CUI [1,3])
    Item
    Yes, check all that apply
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C1707814 (UMLS CUI [1,3])
    Experimental drug, Topotecan, Dose Reduced
    Code List
    Yes, check all that apply
    CL Item
    Neutropenia (1)
    CL Item
    Thrombocytopenia (2)
    CL Item
    Anemia (3)
    CL Item
    Diarrhea (4)
    CL Item
    Nausea and/or Vomiting (5)
    CL Item
    Hand - Foot Syndrome (6)
    CL Item
    Rash (7)
    CL Item
    Other, specify (8)
    Item
    Other, specify
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C1707814 (UMLS CUI [1,3])
    Experimental drug, Topotecan, Dose Reduced
    Code List
    Other, specify
    Item Group
    Treatment Confirmation
    C0087111 (UMLS CUI-1)
    C0750484 (UMLS CUI-2)
    Therapeutic procedure, Correct
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    Therapeutic procedure, Wrong, Reason and justification
    Item
    No, record reason(s)
    text
    C0087111 (UMLS CUI [1,1])
    C3827420 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Item Group
    Lapatinib Compliance
    C1506770 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    Lapatinib, Dispensing medication, Date in time
    Item
    Date Dispensed
    date
    C1506770 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Lapatinib, Dispensed Amount, Tablet Dosage Form
    Item
    Total Number of Tablets Dispensed
    integer
    C1506770 (UMLS CUI [1,1])
    C0805077 (UMLS CUI [1,2])
    C0039225 (UMLS CUI [1,3])
    Lapatinib, Dispensing medication, Return to, Date in time
    Item
    Date Returned
    date
    C1506770 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    C0332156 (UMLS CUI [1,3])
    C0723001 (UMLS CUI [1,4])
    C0011008 (UMLS CUI [1,5])
    Lapatinib, Returned Amount, Tablet Dosage Form
    Item
    Total Number of Tablets Returned
    integer
    C1506770 (UMLS CUI [1,1])
    C2699071 (UMLS CUI [1,2])
    C0039225 (UMLS CUI [1,3])
    Item Group
    Continue in This Arm?
    C0805733 (UMLS CUI-1)
    C2603343 (UMLS CUI-2)
    Continuation status, Clinical Trials
    Item
    Will subject continue in current arm?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
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