0 Ratings

ID

41457

Description

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

Keywords

  1. 10/13/20 10/13/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 13, 2020

DOI

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License

Creative Commons BY 4.0

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    Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

    Cycle 1 - Week 4

    1. StudyEvent: ODM
      1. Cycle 1 - Week 4
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

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

    Date of visit; Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Neurological Examination Worksheet
    Description

    Neurological Examination Worksheet

    Alias
    UMLS CUI-1
    C0027853
    Level of consciousness
    Description

    Level of consciousness

    Data type

    text

    Alias
    UMLS CUI [1]
    C0234425
    Neurological symptoms
    Description

    Neurologic Symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0235031
    Other Neurological Symptoms - Specify neurological symptom
    Description

    Neurologic Symptoms, Other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0235031
    UMLS CUI [1,2]
    C0205394
    Other Neurological Symptoms - CTCAE Grade
    Description

    Neurologic Symptoms, Other, Adverse Event Grade Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0235031
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2985911
    Cranial Nerves and Language - Cranial nerves II-XII
    Description

    Cranial Nerves

    Data type

    text

    Alias
    UMLS CUI [1]
    C0010268
    Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
    Description

    Cranial Nerves, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0010268
    UMLS CUI [1,2]
    C1704258
    Cranial Nerves and Language - Language - Dysphasia or aphasia
    Description

    Dysphasia; Aphasia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0973461
    UMLS CUI [2]
    C0003537
    Strength - Right upper extremity
    Description

    Muscle Strength, Right upper extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230329
    Strength - Right upper extremity - If abnormal, specify the muscle group
    Description

    Muscle Strength, Right upper extremity, Abnormality, Muscle

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230329
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0026845
    Strength - Right upper extremity - Grade
    Description

    Muscle Strength, Right upper extremity, Abnormality, Grade

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230329
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0441800
    Strength - Left upper extremity
    Description

    Muscle Strength, Left upper extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230330
    Strength - Left upper extremity - If abnormal, specify the muscle group
    Description

    Muscle Strength, Left upper extremity, Abnormality, Muscle

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230330
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0026845
    Strength - Left upper extremity - Grade
    Description

    Muscle Strength, Left upper extremity, Abnormality, Grade

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230330
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0441800
    Strength - Right lower extremity
    Description

    Muscle Strength, Right lower extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230415
    Strength - Right lower extremity - If abnormal, specify the muscle group
    Description

    Muscle Strength, Right lower extremity, Abnormality, Muscle

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230415
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0026845
    Strength - Right lower extremity - Grade
    Description

    Muscle Strength, Right lower extremity, Abnormality, Grade

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230415
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0441800
    Strength - Left lower extremity
    Description

    Muscle Strength, Left lower extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230416
    Strength - Left lower extremity - If abnormal, specify the muscle group
    Description

    Muscle Strength, Left lower extremity, Abnormality, Muscle

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230416
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0026845
    Strength - Left lower extremity - Grade
    Description

    Muscle Strength, Left lower extremity, Abnormality, Grade

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C0230416
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0441800
    Sensation
    Description

    Esthesia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0036658
    Sensation - If abnormal, specify location/distribution
    Description

    Esthesia, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036658
    UMLS CUI [1,2]
    C1704258
    Ataxia - Right upper extremity (finger to nose testing)
    Description

    Ataxia, Right upper extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004134
    UMLS CUI [1,2]
    C0230329
    Ataxia - Left upper extremity (finger to nose testing)
    Description

    Ataxia, Left upper extremity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004134
    UMLS CUI [1,2]
    C0230330
    Ataxia - Gait
    Description

    Gait Ataxia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0751837
    Ataxia - Balance (Romberg)
    Description

    Ataxia, Ability to balance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004134
    UMLS CUI [1,2]
    C0560184
    Summary of Tumor-Related Neurological Signs and Symptoms
    Description

    Summary of Tumor-Related Neurological Signs and Symptoms

    Alias
    UMLS CUI-1
    C0235031
    UMLS CUI-2
    C0332281
    UMLS CUI-3
    C0027651
    Overall summary of tumor-related NSS for this visit
    Description

    Neurologic Symptoms, Associated with, Neoplasms

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0235031
    UMLS CUI [1,2]
    C0332281
    UMLS CUI [1,3]
    C0027651
    If checked, please specify NSS
    Description

    Neurologic Symptoms, Associated with, Neoplasms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0235031
    UMLS CUI [1,2]
    C0332281
    UMLS CUI [1,3]
    C0027651
    Is subject being withdrawn from study due to progessive tumor-related symptomatology?
    Description

    Neurologic Symptoms, Associated with, Neoplasms, Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0235031
    UMLS CUI [1,2]
    C0332281
    UMLS CUI [1,3]
    C0027651
    UMLS CUI [1,4]
    C2349954
    Central/Local Lab
    Description

    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?
    Description

    Central Laboratory

    Data type

    boolean

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

    Chemistry, Clinical, Laboratory, Local

    Data type

    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?
    Description

    Hematology finding, Laboratory, Local

    Data type

    boolean

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

    Local Laboratory - Clinical Chemistry

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

    Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier

    Data type

    integer

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

    Laboratory Procedures, Chemistry, Clinical, Laboratory

    Data type

    text

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

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

    Data type

    date

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

    Laboratory Procedures, Alanine aminotransferase measurement, Result

    Data type

    text

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

    Laboratory Procedures, Alanine aminotransferase measurement, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Aspartate aminotransferase measurement

    Data type

    text

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

    Laboratory Procedures, Aspartate aminotransferase measurement, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Bilirubin, total measurement

    Data type

    text

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

    Laboratory Procedures, Bilirubin, total measurement, Result

    Data type

    text

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

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    text

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

    Laboratory Procedures, Glucose measurement

    Data type

    text

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

    Laboratory Procedures, Glucose measurement, Result

    Data type

    text

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

    Laboratory Procedures, Glucose measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Total protein measurement

    Data type

    text

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

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    text

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

    Laboratory Procedures, Potassium measurement

    Data type

    text

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

    Laboratory Procedures, Potassium measurement, Result

    Data type

    text

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

    Laboratory Procedures, Potassium measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Sodium measurement

    Data type

    text

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

    Laboratory Procedures, Sodium measurement, Result

    Data type

    text

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

    Laboratory Procedures, Sodium measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Calcium measurement

    Data type

    text

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

    Laboratory Procedures, Calcium measurement, Result

    Data type

    text

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

    Laboratory Procedures, Calcium measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Alkaline phosphatase measurement

    Data type

    text

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

    Laboratory Procedures, Alkaline phosphatase measurement, Result

    Data type

    text

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

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    text

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

    Laboratory Procedures, Blood urea nitrogen measurement

    Data type

    text

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

    Laboratory Procedures, Blood urea nitrogen measurement, Result

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Urea measurement

    Data type

    text

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

    Laboratory Procedures, Urea measurement, Result

    Data type

    text

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

    Laboratory Procedures, Urea measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Albumin measurement

    Data type

    text

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

    Laboratory Procedures, Albumin measurement, Result

    Data type

    text

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

    Laboratory Procedures, Albumin measurement, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Creatinine measurement, serum

    Data type

    text

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

    Laboratory Procedures, Creatinine measurement, serum, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Creatinine clearance measurement

    Data type

    text

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

    Laboratory Procedures, Creatinine clearance measurement, Result

    Data type

    text

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

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

    Local Laboratory - Hematology

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

    Laboratory Procedures, Hematology finding, Laboratory Identifier

    Data type

    integer

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

    Laboratory Procedures, Hematology finding, Laboratory

    Data type

    text

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

    Laboratory Procedures, Hematology finding, Sampling, Date in time

    Data type

    date

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

    Laboratory Procedures, White Blood Cell Count procedure

    Data type

    text

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

    Laboratory Procedures, White Blood Cell Count procedure, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Red Blood Cell Count measurement

    Data type

    text

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

    Laboratory Procedures, Red Blood Cell Count measurement, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Hemoglobin

    Data type

    text

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

    Laboratory Procedures, Hemoglobin, Result

    Data type

    text

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

    Laboratory Procedures, Hemoglobin, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Hemoglobin level

    Data type

    text

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

    Laboratory Procedures, Hemoglobin level, Result

    Data type

    text

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

    Laboratory Procedures, Hemoglobin level, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Lymphocyte

    Data type

    text

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

    Laboratory Procedures, Lymphocyte, Result

    Data type

    text

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

    Laboratory Procedures, Lymphocyte, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    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
    Description

    Laboratory Procedures, Lymphocyte, Unit of Measure

    Data type

    text

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

    Laboratory Procedures, Monocytes

    Data type

    text

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

    Laboratory Procedures, Monocytes, Result

    Data type

    text

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

    Laboratory Procedures, Monocytes, Result, Unit of Measure

    Data type

    text

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

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

    Data type

    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
    Description

    Laboratory Procedures, Monocytes, Unit of Measure

    Data type

    text

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

    Laboratory Procedures, Eosinophil count procedure

    Data type

    text

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

    Laboratory Procedures, Eosinophil count procedure, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    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
    Description

    Laboratory Procedures, Eosinophil count procedure, Unit of Measure

    Data type

    text

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

    Laboratory Procedures, Blood basophil count (lab test)

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    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
    Description

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

    Data type

    text

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

    Laboratory Procedures, Platelet Count measurement

    Data type

    text

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

    Laboratory Procedures, Platelet Count measurement, Result

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    text

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

    Laboratory Procedures, Neutrophil count

    Data type

    text

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

    Laboratory Procedures, Neutrophil count, Result

    Data type

    text

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

    Laboratory Procedures, Neutrophil count, Result, Unit of Measure

    Data type

    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
    Description

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

    Data type

    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
    Description

    Laboratory Procedures, Neutrophil count, Unit of Measure

    Data type

    text

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

    Central Lab Data

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

    Central Laboratory, Hematology finding, Sampling, Date in time

    Data type

    date

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

    Central Laboratory, Hematology finding, Sampling, Not Done

    Data type

    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
    Description

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

    Data type

    date

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

    Central Laboratory, Chemistry, Clinical, Sampling, Not Done

    Data type

    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
    Description

    Central Laboratory, Hematology finding, Laboratory, Code

    Data type

    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
    Description

    Central Laboratory, Chemistry, Clinical, Laboratory, Code

    Data type

    text

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

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date
    Description

    Vital signs, Date in time

    Data type

    date

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

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Description

    Body Surface Area

    Data type

    float

    Measurement units
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Blood pressure - Systolic
    Description

    Systolic Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure - Diastolic
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature
    Description

    Body Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Continue in This Arm?
    Description

    Continue in This Arm?

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

    Continuation status, Clinical Trials

    Data type

    boolean

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

    Similar models

    Cycle 1 - Week 4

    1. StudyEvent: ODM
      1. Cycle 1 - Week 4
    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
    Neurological Examination Worksheet
    C0027853 (UMLS CUI-1)
    Item
    Level of consciousness
    text
    C0234425 (UMLS CUI [1])
    Code List
    Level of consciousness
    CL Item
    Normal (1)
    CL Item
    Somnolence or sedation not interfering with function (2)
    CL Item
    Somnolence or sedation interfering with function, but not interfering with Activities of Daily Living (ADLs) (3)
    CL Item
    Obtundation or stupor; difficult to arouse; interfering with ADLs (4)
    CL Item
    Coma (5)
    Item
    Neurological symptoms
    text
    C0235031 (UMLS CUI [1])
    Code List
    Neurological symptoms
    CL Item
    No - Asymptomatic (1)
    CL Item
    Headache - Grade 1 (2)
    CL Item
    Headache - Grade 2 (3)
    CL Item
    Headache - Grade 3 (4)
    CL Item
    Headache - Grade 4 (5)
    CL Item
    Dizziness/lightheadedness - Grade 1 (6)
    CL Item
    Dizziness/lightheadedness - Grade 2 (7)
    CL Item
    Dizziness/lightheadedness - Grade 3 (8)
    CL Item
    Dizziness/lightheadedness - Grade 4 (9)
    CL Item
    Vertigo - Grade 1 (10)
    CL Item
    Vertigo - Grade 2 (11)
    CL Item
    Vertigo - Grade 3 (12)
    CL Item
    Vertigo - Grade 4 (13)
    CL Item
    Nausea/vomiting - Grade 1 (14)
    CL Item
    Nausea/vomiting - Grade 2 (15)
    CL Item
    Nausea/vomiting - Grade 3 (16)
    CL Item
    Nausea/vomiting - Grade 4 (17)
    CL Item
    Visual problems - Grade 1 (18)
    CL Item
    Visual problems - Grade 2 (19)
    CL Item
    Visual problems - Grade 3 (20)
    CL Item
    Visual problems - Grade 4 (21)
    CL Item
    Seizure - Grade 1 (22)
    CL Item
    Seizure - Grade 2 (23)
    CL Item
    Seizure - Grade 3 (24)
    CL Item
    Seizure - Grade 4 (25)
    CL Item
    Other, specify other neurological symptom(s) in the Other Neurological Symptoms section (26)
    Neurologic Symptoms, Other
    Item
    Other Neurological Symptoms - Specify neurological symptom
    text
    C0235031 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Other Neurological Symptoms - CTCAE Grade
    text
    C0235031 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2985911 (UMLS CUI [1,3])
    Code List
    Other Neurological Symptoms - CTCAE Grade
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    Item
    Cranial Nerves and Language - Cranial nerves II-XII
    text
    C0010268 (UMLS CUI [1])
    Code List
    Cranial Nerves and Language - Cranial nerves II-XII
    CL Item
    Normal (1)
    CL Item
    Present, not interfering w/ADLs  (2)
    CL Item
    Present, interfering w/ADLs  (3)
    CL Item
    Life-threatening, disabling (4)
    Item
    Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
    text
    C0010268 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Code List
    Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
    Item
    Cranial Nerves and Language - Language - Dysphasia or aphasia
    text
    C0973461 (UMLS CUI [1])
    C0003537 (UMLS CUI [2])
    Code List
    Cranial Nerves and Language - Language - Dysphasia or aphasia
    CL Item
    Absent (1)
    CL Item
    Awareness of receptive or expressive aphasia, not impairing ability to communicate  (2)
    CL Item
    Receptive or expressive dysphasia, impairing ability to communicate (3)
    CL Item
    Inability to communicate (4)
    Item
    Strength - Right upper extremity
    text
    C0517349 (UMLS CUI [1,1])
    C0230329 (UMLS CUI [1,2])
    Code List
    Strength - Right upper extremity
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Strength - Right upper extremity - If abnormal, specify the muscle group
    text
    C0517349 (UMLS CUI [1,1])
    C0230329 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0026845 (UMLS CUI [1,4])
    Code List
    Strength - Right upper extremity - If abnormal, specify the muscle group
    Item
    Strength - Right upper extremity - Grade
    text
    C0517349 (UMLS CUI [1,1])
    C0230329 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    Code List
    Strength - Right upper extremity - Grade
    CL Item
    Grade 1 - asymptomatic with weakness on physical exam (1)
    CL Item
    Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
    CL Item
    Grade 3 - symptomatic and interfering with activities of daily living (3)
    CL Item
    Grade 4 - bedridden or disabling (4)
    Item
    Strength - Left upper extremity
    text
    C0517349 (UMLS CUI [1,1])
    C0230330 (UMLS CUI [1,2])
    Code List
    Strength - Left upper extremity
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Muscle Strength, Left upper extremity, Abnormality, Muscle
    Item
    Strength - Left upper extremity - If abnormal, specify the muscle group
    text
    C0517349 (UMLS CUI [1,1])
    C0230330 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0026845 (UMLS CUI [1,4])
    Item
    Strength - Left upper extremity - Grade
    text
    C0517349 (UMLS CUI [1,1])
    C0230330 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    Code List
    Strength - Left upper extremity - Grade
    CL Item
    Grade 1 - asymptomatic with weakness on physical exam (1)
    CL Item
    Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
    CL Item
    Grade 3 - symptomatic and interfering with activities of daily living (3)
    CL Item
    Grade 4 - bedridden or disabling (4)
    Item
    Strength - Right lower extremity
    text
    C0517349 (UMLS CUI [1,1])
    C0230415 (UMLS CUI [1,2])
    Code List
    Strength - Right lower extremity
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Muscle Strength, Right lower extremity, Abnormality, Muscle
    Item
    Strength - Right lower extremity - If abnormal, specify the muscle group
    text
    C0517349 (UMLS CUI [1,1])
    C0230415 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0026845 (UMLS CUI [1,4])
    Item
    Strength - Right lower extremity - Grade
    text
    C0517349 (UMLS CUI [1,1])
    C0230415 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    Code List
    Strength - Right lower extremity - Grade
    CL Item
    Grade 1 - asymptomatic with weakness on physical exam (1)
    CL Item
    Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
    CL Item
    Grade 3 - symptomatic and interfering with activities of daily living (3)
    CL Item
    Grade 4 - bedridden or disabling (4)
    Item
    Strength - Left lower extremity
    text
    C0517349 (UMLS CUI [1,1])
    C0230416 (UMLS CUI [1,2])
    Code List
    Strength - Left lower extremity
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Muscle Strength, Left lower extremity, Abnormality, Muscle
    Item
    Strength - Left lower extremity - If abnormal, specify the muscle group
    text
    C0517349 (UMLS CUI [1,1])
    C0230416 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0026845 (UMLS CUI [1,4])
    Item
    Strength - Left lower extremity - Grade
    text
    C0517349 (UMLS CUI [1,1])
    C0230416 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    Code List
    Strength - Left lower extremity - Grade
    CL Item
    Grade 1 - asymptomatic with weakness on physical exam (1)
    CL Item
    Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
    CL Item
    Grade 3 - symptomatic and interfering with activities of daily living (3)
    CL Item
    Grade 4 - bedridden or disabling (4)
    Item
    Sensation
    text
    C0036658 (UMLS CUI [1])
    Code List
    Sensation
    CL Item
    Normal (1)
    CL Item
    Loss of deep tendon reflexes or paresthesia, but not interfering with function (2)
    CL Item
    Objective sensory loss or paresthesia interfering with function, but no interfering with ADLs (3)
    CL Item
    Sensory loss or paresthesia interfering with ADLs (4)
    CL Item
    Permanent sensory loss that interferes with function (5)
    Item
    Sensation - If abnormal, specify location/distribution
    text
    C0036658 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Code List
    Sensation - If abnormal, specify location/distribution
    Item
    Ataxia - Right upper extremity (finger to nose testing)
    text
    C0004134 (UMLS CUI [1,1])
    C0230329 (UMLS CUI [1,2])
    Code List
    Ataxia - Right upper extremity (finger to nose testing)
    CL Item
    Normal (1)
    CL Item
    Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
    CL Item
    Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
    CL Item
    Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
    CL Item
    Abnormal - Grade 4 - bedridden or disabling (5)
    Item
    Ataxia - Left upper extremity (finger to nose testing)
    text
    C0004134 (UMLS CUI [1,1])
    C0230330 (UMLS CUI [1,2])
    Code List
    Ataxia - Left upper extremity (finger to nose testing)
    CL Item
    Normal (1)
    CL Item
    Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
    CL Item
    Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
    CL Item
    Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
    CL Item
    Abnormal - Grade 4 - bedridden or disabling (5)
    Item
    Ataxia - Gait
    text
    C0751837 (UMLS CUI [1])
    Code List
    Ataxia - Gait
    CL Item
    Normal (1)
    CL Item
    Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
    CL Item
    Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
    CL Item
    Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
    CL Item
    Abnormal - Grade 4 - bedridden or disabling (5)
    Item
    Ataxia - Balance (Romberg)
    text
    C0004134 (UMLS CUI [1,1])
    C0560184 (UMLS CUI [1,2])
    Code List
    Ataxia - Balance (Romberg)
    CL Item
    Normal (1)
    CL Item
    Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
    CL Item
    Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
    CL Item
    Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
    CL Item
    Abnormal - Grade 4 - bedridden or disabling (5)
    Item Group
    Summary of Tumor-Related Neurological Signs and Symptoms
    C0235031 (UMLS CUI-1)
    C0332281 (UMLS CUI-2)
    C0027651 (UMLS CUI-3)
    Item
    Overall summary of tumor-related NSS for this visit
    text
    C0235031 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [1,3])
    Code List
    Overall summary of tumor-related NSS for this visit
    CL Item
    Improvement. If checked, please specify NSS (1)
    CL Item
    Stable (2)
    CL Item
    Deterioration. If checked, please specify NSS (3)
    Neurologic Symptoms, Associated with, Neoplasms
    Item
    If checked, please specify NSS
    date
    C0235031 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [1,3])
    Neurologic Symptoms, Associated with, Neoplasms, Withdraw
    Item
    Is subject being withdrawn from study due to progessive tumor-related symptomatology?
    boolean
    C0235031 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [1,3])
    C2349954 (UMLS CUI [1,4])
    Item Group
    Central/Local Lab
    C0022885 (UMLS CUI-1)
    C1880016 (UMLS CUI-2)
    C0022885 (UMLS CUI-3)
    C0205276 (UMLS CUI-4)
    Central Laboratory
    Item
    Was a central laboratory used?
    boolean
    C1880016 (UMLS CUI [1])
    Chemistry, Clinical, Laboratory, Local
    Item
    Was a local lab used for Chemistry assessments?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    Hematology finding, Laboratory, Local
    Item
    Was a local lab used for Hematology assessments?
    boolean
    C0474523 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    Item Group
    Local Laboratory - Clinical Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier
    Item
    Laboratory ID
    integer
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C2986056 (UMLS CUI [1,3])
    Item
    Laboratory Used For This Sample
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Code List
    Laboratory Used For This Sample
    CL Item
    Laboratory 1 (1)
    CL Item
    Laboratory 2 (2)
    CL Item
    Laboratory 3 (3)
    CL Item
    Laboratory 4 (4)
    CL Item
    Laboratory 5 (5)
    CL Item
    Laboratory 6 (6)
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    ALT
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    ALT - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Unit of Measure
    Item
    ALT - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Lower limit of reference range
    Item
    ALT - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Alanine aminotransferase measurement, Result, Upper Limit of Normal
    Item
    ALT - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    AST
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    AST - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Unit of Measure
    Item
    AST - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Item
    AST - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Aspartate aminotransferase measurement, Result, Upper Limit of Normal
    Item
    AST - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Total Bilirubin
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Bilirubin, total measurement, Result
    Item
    Total Bilirubin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Bilirubin, total measurement, Result, Unit of Measure
    Item
    Total Bilirubin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Bilirubin, total measurement, Result, Lower limit of reference range
    Item
    Total Bilirubin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Bilirubin, total measurement, Result, Upper Limit of Normal
    Item
    Total Bilirubin - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Glucose
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Glucose measurement, Result
    Item
    Glucose - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Glucose measurement, Result, Unit of Measure
    Item
    Glucose - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Glucose measurement, Result, Upper Limit of Normal
    Item
    Glucose - High
    text
    C0022885 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Total Protein
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Total protein measurement, Result, Unit of Measure
    Item
    Total Protein - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Total protein measurement, Result, Lower limit of reference range
    Item
    Total Protein - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Total protein measurement, Result, Upper Limit of Normal
    Item
    Total Protein - High
    text
    C0022885 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Potassium
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Potassium measurement, Result
    Item
    Potassium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Potassium measurement, Result, Unit of Measure
    Item
    Potassium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Potassium measurement, Result, Lower limit of reference range
    Item
    Potassium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Potassium measurement, Result, Upper Limit of Reference Range
    Item
    Potassium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Sodium
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Sodium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Sodium measurement, Result, Unit of Measure
    Item
    Sodium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Sodium measurement, Result, Lower limit of reference range
    Item
    Sodium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Sodium measurement, Result, Upper Limit of Normal
    Item
    Sodium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Calcium
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Calcium measurement, Result
    Item
    Calcium - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Calcium measurement, Result, Unit of Measure
    Item
    Calcium - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Calcium measurement, Result, Lower limit of reference range
    Item
    Calcium - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Calcium measurement, Result, Upper Limit of Normal
    Item
    Calcium - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Alkaline Phosphatase
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Alkaline Phosphatase - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Code List
    Alkaline Phosphatase - Results
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Unit of Measure
    Item
    Alkaline Phosphatase - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Lower limit of reference range
    Item
    Alkaline Phosphatase - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Alkaline phosphatase measurement, Result, Upper Limit of Normal
    Item
    Alkaline Phosphatase - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    BUN
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    BUN - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Blood urea nitrogen measurement, Result, Upper Limit of Normal
    Item
    BUN - High
    text
    C0022885 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Urea
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Urea - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Urea measurement, Result, Unit of Measure
    Item
    Urea - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Urea measurement, Result, Lower limit of reference range
    Item
    Urea - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Urea measurement, Result, Upper Limit of Normal
    Item
    Urea - High
    text
    C0022885 (UMLS CUI [1,1])
    C0523961 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Albumin
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Albumin measurement, Result
    Item
    Albumin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Albumin measurement, Result, Unit of Measure
    Item
    Albumin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Albumin measurement, Result, Lower limit of reference range
    Item
    Albumin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Albumin measurement, Result, Upper Limit of Normal
    Item
    Albumin - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Creatinine
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Creatinine measurement, serum, Result
    Item
    Creatinine - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Creatinine measurement, serum, Result, Unit of Measure
    Item
    Creatinine - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine measurement, serum, Result, Lower limit of reference range
    Item
    Creatinine - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Laboratory Procedures, Creatinine measurement, serum, Result, Upper Limit of Normal
    Item
    Creatinine - High
    text
    C0022885 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Item
    Creatinine Clearance
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No results (2)
    Laboratory Procedures, Creatinine clearance measurement, Result
    Item
    Creatinine Clearance - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Item
    Creatinine Clearance - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Code List
    Creatinine Clearance - Units
    Laboratory Procedures, Creatinine clearance measurement, Result, Lower limit of reference range
    Item
    Creatinine Clearance - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Creatinine Clearance - High
    text
    C0022885 (UMLS CUI [1,1])
    C0373595 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519815 (UMLS CUI [1,4])
    Code List
    Creatinine Clearance - High
    Item Group
    Local Laboratory - Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Laboratory Procedures, Hematology finding, Laboratory Identifier
    Item
    Laboratory ID
    integer
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C2986056 (UMLS CUI [1,3])
    Item
    Laboratory Used For This Sample
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Code List
    Laboratory Used For This Sample
    CL Item
    Laboratory 1 (1)
    CL Item
    Laboratory 2 (2)
    CL Item
    Laboratory 3 (3)
    CL Item
    Laboratory 4 (4)
    CL Item
    Laboratory 5 (5)
    CL Item
    Laboratory 6 (6)
    Laboratory Procedures, Hematology finding, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    WBC
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, White Blood Cell Count procedure, Result
    Item
    WBC - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, White Blood Cell Count procedure, Result, Unit of Measure
    Item
    WBC - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, White Blood Cell Count procedure, Result, Lower limit of reference range
    Item
    WBC - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    RBC
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    RBC - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Red Blood Cell Count measurement, Result, Unit of Measure
    Item
    RBC - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Red Blood Cell Count measurement, Result, Lower limit of reference range
    Item
    RBC - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Haemoglobin
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Hemoglobin, Result
    Item
    Haemoglobin - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Hemoglobin, Result, Unit of Measure
    Item
    Haemoglobin - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Hemoglobin, Result, Lower limit of reference range
    Item
    Haemoglobin - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Haematocrit
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Hemoglobin level, Result
    Item
    Haematocrit - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Hemoglobin level, Result, Unit of Measure
    Item
    Haematocrit - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Hemoglobin level, Result, Lower limit of reference range
    Item
    Haematocrit - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Lymphocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Lymphocyte, Result
    Item
    Lymphocytes - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Lymphocyte, Result, Unit of Measure
    Item
    Lymphocytes - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Lymphocyte, Result, Lower limit of reference range
    Item
    Lymphocytes - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Lymphocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0024264 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Monocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Monocytes - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Code List
    Monocytes - Results
    Laboratory Procedures, Monocytes, Result, Unit of Measure
    Item
    Monocytes - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Monocytes, Result, Lower limit of reference range
    Item
    Monocytes - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Monocytes
    text
    C0022885 (UMLS CUI [1,1])
    C0026473 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Code List
    Units for Monocytes
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Eosinophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Laboratory Procedures, Eosinophil count procedure, Result
    Item
    Eosinophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Eosinophil count procedure, Result, Unit of Measure
    Item
    Eosinophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Eosinophil count procedure, Result, Lower limit of reference range
    Item
    Eosinophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Unit of Eosinophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200638 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item
    Basophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Basophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Code List
    Basophils - Results
    Laboratory Procedures, Blood basophil count (lab test), Result, Unit of Measure
    Item
    Basophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Blood basophil count (lab test), Result, Lower limit of reference range
    Item
    Basophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Basophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200641 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    CL Item
    Percent  (1)
    CL Item
    Absolute count (2)
    Item
    Platelets
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Platelets - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Platelet Count measurement, Result, Unit of Measure
    Item
    Platelets - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Platelet Count measurement, Result, Lower limit of reference range
    Item
    Platelets - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Total Neutrophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    CL Item
    Results (1)
    CL Item
    No result (2)
    Item
    Total Neutrophils - Results
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Neutrophil count, Result, Unit of Measure
    Item
    Total Neutrophils - Units
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Laboratory Procedures, Neutrophil count, Result, Lower limit of reference range
    Item
    Total Neutrophils - Low
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C1272773 (UMLS CUI [1,4])
    Item
    Units for Neutrophils
    text
    C0022885 (UMLS CUI [1,1])
    C0200633 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    CL Item
    Percent (1)
    CL Item
    Absolute count (2)
    Item Group
    Central Lab Data
    C1880016 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Central Laboratory, Hematology finding, Sampling, Date in time
    Item
    Hematology Date sample taken
    date
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Central Laboratory, Hematology finding, Sampling, Not Done
    Item
    Not Done
    boolean
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Sampling, Date in time
    Item
    Clinical Chemistry Date sample taken
    date
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Sampling, Not Done
    Item
    Not Done
    boolean
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    Central Laboratory, Hematology finding, Laboratory, Code
    Item
    Haem Lab type code
    text
    C1880016 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Central Laboratory, Chemistry, Clinical, Laboratory, Code
    Item
    Chem Lab type code
    text
    C1880016 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital signs, Date in time
    Item
    Actual date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body surface area
    float
    C0005902 (UMLS CUI [1])
    Systolic Pressure
    Item
    Blood pressure - Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure - Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Body Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    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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