ID

41454

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

  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

Cycle 1 - Day 1

  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
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
Prior Visit Prompt
Beschreibung

Prior Visit Prompt

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C0205156
Is the visit date for start of this new cycle occurring on the same date as the Day 1 Pre-dose visit for a new subject, or an End of Cycle assessment at Week 4 or Week 8 for an ongoing subject? If “YES,” then certain assessments do not need to be repeated.
Beschreibung

Visit, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0205156
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
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 Lapatinib
Beschreibung

Investigational Product Lapatinib

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1506770
Sequence number
Beschreibung

Experimental drug, Lapatinib, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C2348184
Investigational Product
Beschreibung

Experimental drug, Lapatinib

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
Infusion Start Date
Beschreibung

Experimental drug, Lapatinib, Infusion procedures, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C0574032
UMLS CUI [1,4]
C0808070
Scheduled Dose
Beschreibung

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

Datentyp

float

Maßeinheiten
  • mg/m2
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205539
mg/m2
Dose Units
Beschreibung

Experimental drug, Lapatinib, Medication dose, Units of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1519795
Actual Dose
Beschreibung

Experimental drug, Lapatinib, Medication dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
mg
Dose Units
Beschreibung

Experimental drug, Lapatinib, Medication dose, Units of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1519795
Was dose delayed?
Beschreibung

Experimental drug, Lapatinib, Medication dose, Deferred

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205421
Yes, check all that apply
Beschreibung

Experimental drug, Lapatinib, Medication dose, Deferred

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205421
Other, specify
Beschreibung

Experimental drug, Lapatinib, Medication dose, Deferred

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205421
Was dose reduced?
Beschreibung

Experimental drug, Lapatinib, Dose Reduced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1707814
Yes, check all that apply
Beschreibung

Experimental drug, Lapatinib, Dose Reduced

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1707814
Other, specify
Beschreibung

Experimental drug, Lapatinib, Dose Reduced

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1707814
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

Ähnliche Modelle

Cycle 1 - Day 1

  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
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
Prior Visit Prompt
C0545082 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
Visit, Previous
Item
Is the visit date for start of this new cycle occurring on the same date as the Day 1 Pre-dose visit for a new subject, or an End of Cycle assessment at Week 4 or Week 8 for an ongoing subject? If “YES,” then certain assessments do not need to be repeated.
boolean
C0545082 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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])
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])
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, 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])
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, 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, 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])
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])
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])
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])
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])
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, 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])
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])
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])
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])
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, 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])
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, 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])
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])
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])
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])
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])
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])
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])
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])
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, 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])
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])
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])
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])
CL Item
Percent (1)
CL Item
Absolute count (2)
Item
Monocytes
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
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])
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])
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])
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])
CL Item
Percent (1)
CL Item
Absolute count (2)
Item
Basophils
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
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])
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])
CL Item
Percent  (1)
CL Item
Absolute count (2)
Item
Platelets
text
C0022885 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
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, 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])
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, 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])
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
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 Lapatinib
C0304229 (UMLS CUI-1)
C1506770 (UMLS CUI-2)
Experimental drug, Lapatinib, Sequence Number
Item
Sequence number
integer
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Item
Investigational Product
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
Code List
Investigational Product
CL Item
Lapatinib (1)
Experimental drug, Lapatinib, Infusion procedures, Start Date
Item
Infusion Start Date
date
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Experimental drug, Lapatinib, Medication dose, Scheduled - procedure status
Item
Scheduled Dose
float
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Experimental drug, Lapatinib, Medication dose, Units of Measure
Item
Dose Units
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Experimental drug, Lapatinib, Medication dose
Item
Actual Dose
float
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Experimental drug, Lapatinib, Medication dose, Units of Measure
Item
Dose Units
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Experimental drug, Lapatinib, Medication dose, Deferred
Item
Was dose delayed?
boolean
C0304229 (UMLS CUI [1,1])
C1506770 (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])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205421 (UMLS CUI [1,4])
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)
Experimental drug, Lapatinib, Medication dose, Deferred
Item
Other, specify
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205421 (UMLS CUI [1,4])
Experimental drug, Lapatinib, Dose Reduced
Item
Was dose reduced?
boolean
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Yes, check all that apply
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
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)
Experimental drug, Lapatinib, Dose Reduced
Item
Other, specify
text
C0304229 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
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])
Code List
Sequence number
Item
Investigational Product
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
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])
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, 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])
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])
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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