Cycle 1 - Day 1

1 forms
  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial