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ID

42088

Description

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Keywords

Versions (2)
  1. 3/25/21 3/25/21 -
  2. 3/30/21 3/30/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 30, 2021

DOI

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License

Creative Commons BY 4.0
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    Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

    English

    Week 3 - 13 and 25 - Laboratory Results; Physical Examination; Post-Treatment Response

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site Number
    Description

    Site Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Laboratory Results (Week 3-13, 25) - Hematology
    Description

    Laboratory Results (Week 3-13, 25) - Hematology

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0018943
    Hematology Date
    Description

    Hematology Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0011008
    Performed at primary lab listed on 1572? (Hematology)
    Description

    Performed at primary lab listed on 1572? (Hematology)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0018943
    Laboratory Results (Week 3-13, 25) - Hematology
    Description

    Laboratory Results (Week 3-13, 25) - Hematology

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0018943
    Laboratory Test (Hematology)
    Description

    Laboratory Test (Hematology)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Laboratory Test Result (Hematology)
    Description

    Laboratory Test Result (Hematology)

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0587081
    Laboratory Results (Week 25) - Hematology
    Description

    Laboratory Results (Week 25) - Hematology

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0018943
    HAMA Date
    Description

    HAMA Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C0011008
    HAMA Result
    Description

    HAMA Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C1274040
    Laboratory Results (Week 3, 13, 25) - Chemistry
    Description

    Laboratory Results (Week 3, 13, 25) - Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0008000
    Chemistry Date
    Description

    Chemistry Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0011008
    Performed at primary lab listed on 1572? (Chemistry)
    Description

    Performed at primary lab listed on 1572? (Chemistry)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    Laboratory Results (Week 3 and 13) - Chemistry
    Description

    Laboratory Results (Week 3 and 13) - Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0008000
    Laboratory Test (Chemistry)
    Description

    Laboratory Test (Chemistry)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Laboratory Test Result (Chemistry)
    Description

    Laboratory Test Result (Chemistry)

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0008000
    Laboratory Results (Week 7) - Chemistry
    Description

    Laboratory Results (Week 7) - Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0008000
    Chemistry Date
    Description

    Chemistry Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0011008
    Performed at primary lab listed on 1572? (Chemistry)
    Description

    Performed at primary lab listed on 1572? (Chemistry)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    Laboratory Results (Week 7) - Chemistry
    Description

    Laboratory Results (Week 7) - Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0008000
    Laboratory Test (Chemistry)
    Description

    Laboratory Test (Chemistry)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0525044
    HAMA Date
    Description

    HAMA Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C0011008
    HAMA Result
    Description

    HAMA Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C1274040
    Laboratory Results (Week 25) - Chemistry
    Description

    Laboratory Results (Week 25) - Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0008000
    Laboratory Test (Chemistry)
    Description

    Laboratory Test (Chemistry)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Laboratory Test Result (Chemistry)
    Description

    Laboratory Test Result (Chemistry)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0008000
    Physical Examination (Week 7, 13, 25)
    Description

    Physical Examination (Week 7, 13, 25)

    Alias
    UMLS CUI-1
    C0031809
    Does the patient currently have evidence of "B" symptoms?
    Description

    Does the patient currently have evidence of

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1706867
    UMLS CUI [1,2]
    C0521116
    Current "B" symptoms
    Description

    Current

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1706867
    Date of physical examination
    Description

    Date of physical examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Karnofsky Status
    Description

    Karnofsky Status

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0206065
    %
    Respirations
    Description

    Respirations

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0035203
    breaths/min
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Physical Examination (Week 7, 13, 25)
    Description

    Physical Examination (Week 7, 13, 25)

    Alias
    UMLS CUI-1
    C0031809
    Organ/ System
    Description

    Organ/ System

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0678852
    Result
    Description

    Result

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1274040
    If abnormal, specify
    Description

    If abnormal, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C2348235
    Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results
    Description

    Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0040405
    UMLS CUI-3
    C0011923
    UMLS CUI-4
    C1274040
    Organ/System
    Description

    Organ/System

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0678852
    Imaging Date
    Description

    Imaging Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0011008
    Imaging Not done
    Description

    Imaging Not done

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1272696
    Radiological Imaging
    Description

    Radiological Imaging

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1275506
    Specify other radiological imaging
    Description

    Specify other radiological imaging

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1275506
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
    Radiological Imaging Result
    Description

    Radiological Imaging Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1274040
    Specify abnormal Imaging result
    Description

    Specify abnormal Imaging result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C2826279
    UMLS CUI [1,3]
    C2348235
    Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy
    Description

    Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0699749
    UMLS CUI-3
    C0005954
    Date of biopsy
    Description

    Date of biopsy

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    Bone Marrow Biopsy not done/not indicated
    Description

    Bone Marrow Biopsy not done/not indicated

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005954
    UMLS CUI [2]
    C1272696
    UMLS CUI [3]
    C3146298
    Marrow cellularity
    Description

    Marrow cellularity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1561532
    Tumor involvement
    Description

    Tumor involvement

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    %
    Tumor involvement
    Description

    Tumor involvement

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    Post-Treatment Response (Week 7 and 13) - Received medication/transfusion
    Description

    Post-Treatment Response (Week 7 and 13) - Received medication/transfusion

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C1879316
    Has the patient received medication/transfusion?
    Description

    Check all that apply

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013227
    UMLS CUI [2]
    C1879316
    Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease
    Description

    Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0024299
    UMLS CUI-3
    C1513041
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C1515974
    Method of Determination
    Description

    Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date of Measurement
    Description

    Date of Measurement

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0242485
    Tumor Measurments - Diameter 1
    Description

    Tumor Measurments - Diameter 1

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0475440
    UMLS CUI [1,2]
    C1301886
    cm
    Tumor Measurments - Diameter 2
    Description

    Tumor Measurments - Diameter 2

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0475440
    UMLS CUI [1,2]
    C1301886
    cm
    Tumor Measurment Result
    Description

    Tumor Measurment Result

    Data type

    float

    Measurement units
    • cm^2
    Alias
    UMLS CUI [1,1]
    C0475440
    UMLS CUI [1,2]
    C1274040
    cm^2
    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
    Description

    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0024299
    Non-Measurable Lymphoma Disease - Check if None
    Description

    Non-Measurable Lymphoma Disease - Check if None

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C1334988
    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
    Description

    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0024299
    UMLS CUI-3
    C1334988
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C1515974
    Method of Determination
    Description

    Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date of Measurement
    Description

    Date of Measurement

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0242485
    Disease Status
    Description

    Check one

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Post-Treatment Response (Week 7, 13, 25) - Response
    Description

    Post-Treatment Response (Week 7, 13, 25) - Response

    Alias
    UMLS CUI-1
    C0521982
    Response
    Description

    Response

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0521982
    Date of Response Evaluation
    Description

    Date of Response Evaluation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0011008
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Signature of Investigator
    Description

    Signature of Investigator

    Alias
    UMLS CUI-1
    C2346576
    Signature of Investigator
    Description

    Signature of Investigator

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Signature of Investigator Date
    Description

    Signature of Investigator Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Week 3 - 13 and 25 - Laboratory Results; Physical Examination; Post-Treatment Response

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Site Number
    Item
    Site Number
    text
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Laboratory Results (Week 3-13, 25) - Hematology
    C1254595 (UMLS CUI-1)
    C0018943 (UMLS CUI-2)
    Hematology Date
    Item
    Hematology Date
    date
    C0474523 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Performed at primary lab listed on 1572? (Hematology)
    Item
    Performed at primary lab listed on 1572? (Hematology)
    boolean
    C0022885 (UMLS CUI [1,1])
    C0018943 (UMLS CUI [1,2])
    Item Group
    Laboratory Results (Week 3-13, 25) - Hematology
    C1254595 (UMLS CUI-1)
    C0018943 (UMLS CUI-2)
    Item
    Laboratory Test (Hematology)
    integer
    C0018941 (UMLS CUI [1])
    Laboratory Test (Hematology)
    Code List
    Laboratory Test (Hematology)
    CL Item
    WBC (10^3/mm^3) (1)
    CL Item
    RBC (10^6/mm^3) (2)
    CL Item
    Hemoglobin (g/dL) (3)
    CL Item
    Hematocrit (%) (4)
    CL Item
    Platelet Count (10^3/mm^3) (5)
    CL Item
    Neutrophils (10^3/mm^3) (segs + bands) (6)
    CL Item
    Lymphocytes (10^3/mm^3) (7)
    CL Item
    Monocytes (10^3/mm^3) (8)
    CL Item
    Eosinophils (10^3/mm^3) (9)
    CL Item
    Basophils (10^3/mm^3) (10)
    CL Item
    Other Differential (10^3/mm^3) (11)
    Laboratory Test Result (Hematology)
    Item
    Laboratory Test Result (Hematology)
    float
    C0018941 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Item Group
    Laboratory Results (Week 25) - Hematology
    C1254595 (UMLS CUI-1)
    C0018943 (UMLS CUI-2)
    HAMA Date
    Item
    HAMA Date
    date
    C1291910 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    HAMA Result
    integer
    C1291910 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    HAMA Result
    Code List
    HAMA Result
    CL Item
    Pos (1)
    CL Item
    Neg (2)
    Item Group
    Laboratory Results (Week 3, 13, 25) - Chemistry
    C1254595 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Chemistry Date
    Item
    Chemistry Date
    date
    C0008000 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Performed at primary lab listed on 1572? (Chemistry)
    Item
    Performed at primary lab listed on 1572? (Chemistry)
    boolean
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item Group
    Laboratory Results (Week 3 and 13) - Chemistry
    C1254595 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Laboratory Test (Chemistry)
    integer
    C0525044 (UMLS CUI [1])
    Laboratory Test (Chemistry)
    Code List
    Laboratory Test (Chemistry)
    CL Item
    Sodium (mEq/L) (1)
    CL Item
    Potassium (mEq/L) (2)
    CL Item
    Chloride (mEq/L) (3)
    CL Item
    BUN (mg/dL) (4)
    CL Item
    Creatinine (mg/dL) (5)
    CL Item
    AST/GOT (IU/L) (6)
    CL Item
    Alkaline Phosphatase (IU/L) (7)
    CL Item
    LDH (IU/L) (8)
    CL Item
    Total Bilirubin (mg/dL) (9)
    Laboratory Test Result (Chemistry)
    Item
    Laboratory Test Result (Chemistry)
    float
    C0587081 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item Group
    Laboratory Results (Week 7) - Chemistry
    C1254595 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Chemistry Date
    Item
    Chemistry Date
    date
    C0008000 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Performed at primary lab listed on 1572? (Chemistry)
    Item
    Performed at primary lab listed on 1572? (Chemistry)
    boolean
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item Group
    Laboratory Results (Week 7) - Chemistry
    C1254595 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Laboratory Test (Chemistry)
    text
    C0525044 (UMLS CUI [1])
    Laboratory Test (Chemistry)
    Code List
    Laboratory Test (Chemistry)
    CL Item
    Sodium (mEq/L) (1)
    CL Item
    Potassium (mEq/L) (2)
    CL Item
    Chloride (mEq/L) (3)
    CL Item
    BUN (mg/dL) (4)
    CL Item
    Creatinine (mg/dL) (5)
    CL Item
    AST/GOT (IU/L) (6)
    CL Item
    Alkaline Phosphatase (IU/L) (7)
    CL Item
    LDH (IU/L) (8)
    CL Item
    Total Bilirubin (mg/dL) (9)
    CL Item
    HAMA (10)
    HAMA Date
    Item
    HAMA Date
    date
    C1291910 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    HAMA Result
    integer
    C1291910 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    HAMA Result
    Code List
    HAMA Result
    CL Item
    Pos  (1)
    CL Item
    Neg (2)
    Item Group
    Laboratory Results (Week 25) - Chemistry
    C1254595 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Laboratory Test (Chemistry)
    integer
    C0525044 (UMLS CUI [1])
    Laboratory Test (Chemistry)
    Code List
    Laboratory Test (Chemistry)
    CL Item
    Sodium (mEq/L) (1)
    CL Item
    Potassium (mEq/L) (2)
    CL Item
    Chloride (mEq/L) (3)
    CL Item
    BUN (mg/dL) (4)
    CL Item
    Creatinine (mg/dL) (5)
    CL Item
    AST/GOT (IU/L) (6)
    CL Item
    Alkaline Phosphatase (IU/L) (7)
    CL Item
    LDH (IU/L) (8)
    CL Item
    Total Bilirubin (mg/dL) (9)
    CL Item
    TSH (uU7mL) (10)
    CL Item
    Total T3 (mg/dL) (11)
    CL Item
    Free T4 (ug/dL) (12)
    Laboratory Test Result (Chemistry)
    Item
    Laboratory Test Result (Chemistry)
    text
    C0587081 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item Group
    Physical Examination (Week 7, 13, 25)
    C0031809 (UMLS CUI-1)
    Item
    Does the patient currently have evidence of "B" symptoms?
    text
    C1706867 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Does the patient currently have evidence of "B" symptoms?
    Code List
    Does the patient currently have evidence of "B" symptoms?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Done (ND)
    Item
    Current "B" symptoms
    integer
    C1706867 (UMLS CUI [1])
    Current "B" symptoms
    Code List
    Current "B" symptoms
    CL Item
    Night sweats (1)
    CL Item
    Intermittent fevers (2)
    CL Item
    Weight loss (3)
    Date of physical examination
    Item
    Date of physical examination
    date
    C2826643 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Karnofsky Status
    Item
    Karnofsky Status
    integer
    C0206065 (UMLS CUI [1])
    Respirations
    Item
    Respirations
    integer
    C0035203 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Physical Examination (Week 7, 13, 25)
    C0031809 (UMLS CUI-1)
    Item
    Organ/ System
    integer
    C0678852 (UMLS CUI [1])
    Organ/ System
    Code List
    Organ/ System
    CL Item
    General Appearance (1)
    CL Item
    Skin (2)
    CL Item
    HEENT (3)
    CL Item
    Neck (4)
    CL Item
    Lymph Nodes (5)
    CL Item
    Lungs (6)
    CL Item
    Heart (7)
    CL Item
    Neurological (8)
    CL Item
    Genitourinary (9)
    CL Item
    Abdomen (10)
    CL Item
    Musculoskeletal (11)
    CL Item
    Other (12)
    Item
    Result
    integer
    C1274040 (UMLS CUI [1])
    Result
    Code List
    Result
    CL Item
    Not Done (1)
    CL Item
    Normal (2)
    CL Item
    Abnormal (3)
    If abnormal, specify
    Item
    If abnormal, specify
    text
    C0243095 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results
    C0521982 (UMLS CUI-1)
    C0040405 (UMLS CUI-2)
    C0011923 (UMLS CUI-3)
    C1274040 (UMLS CUI-4)
    Item
    Organ/System
    integer
    C0678852 (UMLS CUI [1])
    Organ/System
    Code List
    Organ/System
    CL Item
    Head/Neck  (1)
    CL Item
    Chest  (2)
    CL Item
    Abdomen  (3)
    CL Item
    Pelvis  (4)
    CL Item
    Other (5)
    Imaging Date
    Item
    Imaging Date
    date
    C0011923 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Imaging Not done
    integer
    C0011923 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Imaging Not done
    Code List
    Imaging Not done
    CL Item
    Not Done (1)
    Item
    Radiological Imaging
    integer
    C0011923 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    Radiological Imaging
    Code List
    Radiological Imaging
    CL Item
    CT  (1)
    CL Item
    MRI  (2)
    CL Item
    X-ray  (3)
    CL Item
    Other (4)
    Specify other radiological imaging
    Item
    Specify other radiological imaging
    text
    C0011923 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Item
    Radiological Imaging Result
    integer
    C0011923 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Radiological Imaging Result
    Code List
    Radiological Imaging Result
    CL Item
    Normal  (1)
    CL Item
    Abnormal (specify) (2)
    Specify abnormal Imaging result
    Item
    Specify abnormal Imaging result
    text
    C0011923 (UMLS CUI [1,1])
    C2826279 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy
    C0521982 (UMLS CUI-1)
    C0699749 (UMLS CUI-2)
    C0005954 (UMLS CUI-3)
    Date of biopsy
    Item
    Date of biopsy
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Bone Marrow Biopsy not done/not indicated
    integer
    C0005954 (UMLS CUI [1])
    C1272696 (UMLS CUI [2])
    C3146298 (UMLS CUI [3])
    Bone Marrow Biopsy not done/not indicated
    Code List
    Bone Marrow Biopsy not done/not indicated
    CL Item
    Not done (1)
    CL Item
    Not indicated (patient not in CCR or CR) (2)
    Item
    Marrow cellularity
    integer
    C1561532 (UMLS CUI [1])
    Marrow cellularity
    Code List
    Marrow cellularity
    CL Item
    Normal  (1)
    CL Item
    Hypocellular  (2)
    CL Item
    Hypercellular (3)
    Tumor involvement
    Item
    Tumor involvement
    float
    C0006826 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    Item
    Tumor involvement
    integer
    C0006826 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    Tumor involvement
    Code List
    Tumor involvement
    CL Item
    Unilateral  (1)
    CL Item
    Bilateral (2)
    Item Group
    Post-Treatment Response (Week 7 and 13) - Received medication/transfusion
    C0521982 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C1879316 (UMLS CUI-3)
    Item
    Has the patient received medication/transfusion?
    integer
    C0013227 (UMLS CUI [1])
    C1879316 (UMLS CUI [2])
    Has the patient received medication/transfusion?
    Code List
    Has the patient received medication/transfusion?
    CL Item
    G-CSF/GM-CSF (1)
    CL Item
    Platelet transfusion (2)
    CL Item
    RBC transfusion (3)
    CL Item
    Erythropoitein (4)
    CL Item
    Thrombopoietin (5)
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease
    C0521982 (UMLS CUI-1)
    C0024299 (UMLS CUI-2)
    C1513041 (UMLS CUI-3)
    Site
    Item
    Site
    text
    C1515974 (UMLS CUI [1])
    Method of Determination
    Item
    Method of Determination
    text
    C2911685 (UMLS CUI [1])
    Date of Measurement
    Item
    Date of Measurement
    date
    C0011008 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Tumor Measurments - Diameter 1
    Item
    Tumor Measurments - Diameter 1
    float
    C0475440 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Tumor Measurments - Diameter 2
    Item
    Tumor Measurments - Diameter 2
    float
    C0475440 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Tumor Measurment Result
    Item
    Tumor Measurment Result
    float
    C0475440 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
    C0521982 (UMLS CUI-1)
    C0024299 (UMLS CUI-2)
    Item
    Non-Measurable Lymphoma Disease - Check if None
    integer
    C0024299 (UMLS CUI [1,1])
    C1334988 (UMLS CUI [1,2])
    Non-Measurable Lymphoma Disease - Check if None
    Code List
    Non-Measurable Lymphoma Disease - Check if None
    CL Item
    None (1)
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
    C0521982 (UMLS CUI-1)
    C0024299 (UMLS CUI-2)
    C1334988 (UMLS CUI-3)
    Site
    Item
    Site
    text
    C1515974 (UMLS CUI [1])
    Method of Determination
    Item
    Method of Determination
    text
    C2911685 (UMLS CUI [1])
    Date of Measurement
    Item
    Date of Measurement
    date
    C0011008 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item
    Disease Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Disease Status
    Code List
    Disease Status
    CL Item
    New (1)
    CL Item
    Increased (2)
    CL Item
    Stable (3)
    CL Item
    Decreased (4)
    Item Group
    Post-Treatment Response (Week 7, 13, 25) - Response
    C0521982 (UMLS CUI-1)
    Item
    Response
    integer
    C0521982 (UMLS CUI [1])
    Response
    Code List
    Response
    CL Item
    PD (1)
    CL Item
    SD (2)
    CL Item
    PR (3)
    CL Item
    CCR (4)
    CL Item
    CR (5)
    Date of Response Evaluation
    Item
    Date of Response Evaluation
    date
    C0521982 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Signature of Investigator
    C2346576 (UMLS CUI-1)
    Signature of Investigator
    Item
    Signature of Investigator
    text
    C2346576 (UMLS CUI [1])
    Signature of Investigator Date
    Item
    Signature of Investigator Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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