ID

41454

Descripción

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

Palabras clave

Versiones (1)
  1. 13/10/20 13/10/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de octubre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Cycle 1 - Day 1

1 formularios  
  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
Date of Visit/Assessment
Descripción

Date of Visit/Assessment

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

Date of visit; Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Prior Visit Prompt
Descripción

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.
Descripción

Visit, Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0205156
Central/Local Lab
Descripción

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?
Descripción

Central Laboratory

Tipo de datos

boolean

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

Chemistry, Clinical, Laboratory, Local

Tipo de datos

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?
Descripción

Hematology finding, Laboratory, Local

Tipo de datos

boolean

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

Local Laboratory - Clinical Chemistry

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

Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier

Tipo de datos

integer

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

Laboratory Procedures, Chemistry, Clinical, Laboratory

Tipo de datos

text

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

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

Tipo de datos

date

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

Laboratory Procedures, Alanine aminotransferase measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Alanine aminotransferase measurement, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Aspartate aminotransferase measurement

Tipo de datos

text

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

Laboratory Procedures, Aspartate aminotransferase measurement, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Bilirubin, total measurement

Tipo de datos

text

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

Laboratory Procedures, Bilirubin, total measurement, Result

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

text

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

Laboratory Procedures, Glucose measurement

Tipo de datos

text

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

Laboratory Procedures, Glucose measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Glucose measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Total protein measurement

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

text

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

Laboratory Procedures, Potassium measurement

Tipo de datos

text

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

Laboratory Procedures, Potassium measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Potassium measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Sodium measurement

Tipo de datos

text

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

Laboratory Procedures, Sodium measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Sodium measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Calcium measurement

Tipo de datos

text

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

Laboratory Procedures, Calcium measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Calcium measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Alkaline phosphatase measurement

Tipo de datos

text

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

Laboratory Procedures, Alkaline phosphatase measurement, Result

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

text

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

Laboratory Procedures, Blood urea nitrogen measurement

Tipo de datos

text

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

Laboratory Procedures, Blood urea nitrogen measurement, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Urea measurement

Tipo de datos

text

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

Laboratory Procedures, Urea measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Urea measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Albumin measurement

Tipo de datos

text

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

Laboratory Procedures, Albumin measurement, Result

Tipo de datos

text

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

Laboratory Procedures, Albumin measurement, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Creatinine measurement, serum

Tipo de datos

text

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

Laboratory Procedures, Creatinine measurement, serum, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Creatinine clearance measurement

Tipo de datos

text

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

Laboratory Procedures, Creatinine clearance measurement, Result

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Local Laboratory - Hematology

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

Laboratory Procedures, Hematology finding, Laboratory Identifier

Tipo de datos

integer

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

Laboratory Procedures, Hematology finding, Laboratory

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Sampling, Date in time

Tipo de datos

date

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

Laboratory Procedures, White Blood Cell Count procedure

Tipo de datos

text

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

Laboratory Procedures, White Blood Cell Count procedure, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Red Blood Cell Count measurement

Tipo de datos

text

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

Laboratory Procedures, Red Blood Cell Count measurement, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin, Result

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin level

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin level, Result

Tipo de datos

text

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

Laboratory Procedures, Hemoglobin level, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Lymphocyte

Tipo de datos

text

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

Laboratory Procedures, Lymphocyte, Result

Tipo de datos

text

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

Laboratory Procedures, Lymphocyte, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Lymphocyte, Unit of Measure

Tipo de datos

text

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

Laboratory Procedures, Monocytes

Tipo de datos

text

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

Laboratory Procedures, Monocytes, Result

Tipo de datos

text

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

Laboratory Procedures, Monocytes, Result, Unit of Measure

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Monocytes, Unit of Measure

Tipo de datos

text

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

Laboratory Procedures, Eosinophil count procedure

Tipo de datos

text

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

Laboratory Procedures, Eosinophil count procedure, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Eosinophil count procedure, Unit of Measure

Tipo de datos

text

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

Laboratory Procedures, Blood basophil count (lab test)

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

text

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

Laboratory Procedures, Platelet Count measurement

Tipo de datos

text

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

Laboratory Procedures, Platelet Count measurement, Result

Tipo de datos

text

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

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

Tipo de datos

text

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

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

Tipo de datos

text

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

Laboratory Procedures, Neutrophil count

Tipo de datos

text

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

Laboratory Procedures, Neutrophil count, Result

Tipo de datos

text

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

Laboratory Procedures, Neutrophil count, Result, Unit of Measure

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Laboratory Procedures, Neutrophil count, Unit of Measure

Tipo de datos

text

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

Central Lab Data

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

Central Laboratory, Hematology finding, Sampling, Date in time

Tipo de datos

date

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

Central Laboratory, Hematology finding, Sampling, Not Done

Tipo de datos

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
Descripción

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

Tipo de datos

date

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

Central Laboratory, Chemistry, Clinical, Sampling, Not Done

Tipo de datos

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
Descripción

Central Laboratory, Hematology finding, Laboratory, Code

Tipo de datos

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
Descripción

Central Laboratory, Chemistry, Clinical, Laboratory, Code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date
Descripción

Vital signs, Date in time

Tipo de datos

date

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

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Blood pressure - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Descripción

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Investigational Product Lapatinib
Descripción

Investigational Product Lapatinib

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

Experimental drug, Lapatinib, Sequence Number

Tipo de datos

integer

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

Experimental drug, Lapatinib

Tipo de datos

text

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

Experimental drug, Lapatinib, Infusion procedures, Start Date

Tipo de datos

date

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

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

Tipo de datos

float

Unidades de medida
  • 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
Descripción

Experimental drug, Lapatinib, Medication dose, Units of Measure

Tipo de datos

text

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

Experimental drug, Lapatinib, Medication dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C3174092
mg
Dose Units
Descripción

Experimental drug, Lapatinib, Medication dose, Units of Measure

Tipo de datos

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?
Descripción

Experimental drug, Lapatinib, Medication dose, Deferred

Tipo de datos

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
Descripción

Experimental drug, Lapatinib, Medication dose, Deferred

Tipo de datos

text

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

Experimental drug, Lapatinib, Medication dose, Deferred

Tipo de datos

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?
Descripción

Experimental drug, Lapatinib, Dose Reduced

Tipo de datos

boolean

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

Experimental drug, Lapatinib, Dose Reduced

Tipo de datos

text

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

Experimental drug, Lapatinib, Dose Reduced

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1707814
Investigational Product - IV Topotecan Dosing
Descripción

Investigational Product - IV Topotecan Dosing

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

Experimental drug, Topotecan, Sequence Number

Tipo de datos

integer

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

Experimental drug, Topotecan

Tipo de datos

text

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

Experimental drug, Topotecan, Infusion procedures, Start Date

Tipo de datos

date

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

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

Tipo de datos

float

Unidades de medida
  • 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
Descripción

Experimental drug, Topotecan, Medication dose, Units of Measure

Tipo de datos

text

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

Experimental drug, Topotecan, Medication dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3174092
mg
Dose Units
Descripción

Experimental drug, Topotecan, Medication dose, Units of Measure

Tipo de datos

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?
Descripción

Experimental drug, Topotecan, Medication dose, Deferred

Tipo de datos

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
Descripción

Experimental drug, Topotecan, Medication dose, Deferred

Tipo de datos

text

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

Experimental drug, Topotecan, Medication dose, Deferred

Tipo de datos

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?
Descripción

Experimental drug, Topotecan, Dose Reduced

Tipo de datos

boolean

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

Experimental drug, Topotecan, Dose Reduced

Tipo de datos

text

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

Experimental drug, Topotecan, Dose Reduced

Tipo de datos

text

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

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?
Descripción

Therapeutic procedure, Correct

Tipo de datos

boolean

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

Therapeutic procedure, Wrong, Reason and justification

Tipo de datos

text

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

Lapatinib Compliance

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

Lapatinib, Dispensing medication, Date in time

Tipo de datos

date

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

Lapatinib, Dispensed Amount, Tablet Dosage Form

Tipo de datos

integer

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

Lapatinib, Dispensing medication, Return to, Date in time

Tipo de datos

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
Descripción

Lapatinib, Returned Amount, Tablet Dosage Form

Tipo de datos

integer

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

Continue in This Arm?

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

Continuation status, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
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Similar models

Cycle 1 - Day 1

1 formularios
  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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
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])
Level of consciousness
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])
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)
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])
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)
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])
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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