0 Evaluaciones
ID

44907

Descripción

https://clinicaltrials.gov/show/NCT00989664 Eligibility check Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Palabras clave

Versiones (2)
  1. 18/5/18 18/5/18 - Halim Ugurlu
  2. 6/4/22 6/4/22 - Martin Dugas
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

6 de abril de 2022

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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    Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

    Inglés

    Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

    1 formularios  
    1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
      1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
    Administration
    Descripción

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Site Number:
    Descripción

    Site Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Laboratory Results Baseline
    Descripción

    Laboratory Results Baseline

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Hematology Date
    Descripción

    Hematology Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0011008
    Lab # (Worksheet B)
    Descripción

    Lab Nr.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0022877
    WBC
    Descripción

    WBC

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0023508
    RBC
    Descripción

    RBC

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0014772
    Hemoglobin
    Descripción

    Hemoglobin

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0019046
    Hematocrit
    Descripción

    Hematocrit

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0518014
    Platelets
    Descripción

    Platelets

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005821
    Neutrophils
    Descripción

    Neutrophils

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0200633
    Lymphocytes
    Descripción

    Lymphocytes

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0200635
    Monocytes
    Descripción

    Monocytes

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0200637
    Eosinophils
    Descripción

    Eosinophils

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0200638
    Basophils
    Descripción

    Basophils

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0200641
    Other Differential
    Descripción

    Other Differential

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0205394
    Absolute Neutrophile Count-ANC (10³/mm³)
    Descripción

    ANC-Absolute Neutrophile Count

    Tipo de datos

    float

    Unidades de medida
    • 10³/mm³
    Alias
    UMLS CUI [1]
    C0948762
    10³/mm³
    Laboratory Tests-Blood Chemistry
    Descripción

    Laboratory Tests-Blood Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0005774
    Chemistry Date
    Descripción

    Chemistry Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005774
    Lab # (Worksheet B)
    Descripción

    Lab Nr.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0022877
    Sodium
    Descripción

    Sodium

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Descripción

    Potassium

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202194
    Chloride
    Descripción

    Chloride

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201952
    BUN
    Descripción

    BUN

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005845
    Creatinine
    Descripción

    Creatinine

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201976
    AST (SGOT)
    Descripción

    AST (SGOT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201899
    ALT (SGPT)
    Descripción

    ALT (SGPT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201836
    Alkaline Phosphatase
    Descripción

    Alkaline Phosphatase

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201850
    LDH
    Descripción

    LDH

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202113
    Total Bilirubin
    Descripción

    Total Bilirubin

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201913
    TSH
    Descripción

    TSH

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202230
    Total T3
    Descripción

    Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0428419
    Free T4
    Descripción

    Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202225
    Pregnancy Test
    Descripción

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    N/A
    Descripción

    N/A

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1272460
    UMLS CUI [1,2]
    C0032976
    Date
    Descripción

    Must be obtained within 7 days of study entry

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0032976
    Sample
    Descripción

    Sample

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0032976
    Result
    Descripción

    Result

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0427777
    Beta-2 Microglobulin (Serum)
    Descripción

    Beta-2 Microglobulin (Serum)

    Alias
    UMLS CUI-1
    C0005149
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0022885
    UMLS CUI [1,3]
    C0005149
    Result
    Descripción

    Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0005149
    Infusion Record Dosimetric Dose - Day 0 and Day 7
    Descripción

    Infusion Record Dosimetric Dose - Day 0 and Day 7

    Alias
    UMLS CUI-1
    C0574032
    UMLS CUI-2
    C2094191
    Date Administered
    Descripción

    Date Administered

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    Baseline HAMA (human antimurine antibody)
    Descripción

    Baseline HAMA (human antimurine antibody)

    Alias
    UMLS CUI-1
    C1291910
    UMLS CUI-2
    C1442488
    Baseline HAMA date
    Descripción

    Baseline HAMA date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [1,3]
    C0011008
    Baseline HAMA Result
    Descripción

    Baseline HAMA Result

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1442488
    UMLS CUI [1,2]
    C1291910
    UMLS CUI [1,3]
    C1274040
    Dosimetric Dose
    Descripción

    Dosimetric Dose

    Alias
    UMLS CUI-1
    C2094191
    Time Started (24 hour clock) (cold)
    Descripción

    Time Started (cold)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1301880
    Time Finished (24 hour clock) (cold)
    Descripción

    Time Finished (24 hour clock) (cold)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1522314
    Time Started (24 hour clock) (cold flush)
    Descripción

    Time Started (24 hour clock) (cold flush)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1301880
    Time Finished (24 hour clock) (cold flush)
    Descripción

    Time Finished (24 hour clock) (cold flush)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1522314
    Time Started (24 hour clock) (hot)
    Descripción

    Time Started (24 hour clock) (hot)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1301880
    Time Finished (24 hour clock) (hot)
    Descripción

    Time Finished (24 hour clock) (hot)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1522314
    Time Started (24 hour clock) (hot flush)
    Descripción

    Time Started (24 hour clock) (hot flush)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1301880
    Time Finished (24 hour clock) (hot flush)
    Descripción

    Time Finished (24 hour clock) (hot flush)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C1522314
    Anti-B1 Dose
    Descripción

    Anti-B1 Dose

    Alias
    UMLS CUI-1
    C0768182
    UMLS CUI-2
    C3174092
    Anti-B1 Dose (cold dose)
    Descripción

    Anti-B1 Dose (cold dose)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0768182
    UMLS CUI [1,2]
    C3174092
    mg
    Lot number of Anti-B1 (cold)
    Descripción

    Lot number of Anti-B1 (cold)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1115660
    UMLS CUI [1,2]
    C0768182
    Anti-B1 Dose (hot dose)
    Descripción

    Anti-B1 Dose (hot dose)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0768182
    UMLS CUI [1,2]
    C3174092
    mg
    Lot number of Anti-B1 (hot)
    Descripción

    Lot number of Anti-B1 (hot)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1115660
    UMLS CUI [1,2]
    C0768182
    Iodine-131 Anti-B1 (prescribed)
    Descripción

    Iodine-131 Anti-B1 (prescribed)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0768182
    Lot Number (Nordion)
    Descripción

    Lot Number (Nordion)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1115660
    UMLS CUI [1,2]
    C3854006
    Infusion Rate
    Descripción

    Infusion Rate

    Alias
    UMLS CUI-1
    C2964135
    Did infusion rate need to be adjusted?
    Descripción

    Infusion rate need to be adjusted?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2964135
    UMLS CUI [1,2]
    C2826232
    If yes, was infusion rate
    Descripción

    If yes, was infusion rate

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2964135
    UMLS CUI [1,2]
    C2826232
    If the infusion rate was adjusted, was it for (check all that apply)
    Descripción

    If the infusion rate was adjusted, was it for (check all that apply)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2964135
    UMLS CUI [1,2]
    C2826232
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Time (24 hr)
    Descripción

    Time (24 hr)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    Blood Pressure (mmhg)
    Descripción

    BP

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005823
    Pulse
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temp. (C)
    Descripción

    Temp

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005903
    Comments
    Descripción

    Comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Adverse Experiences
    Descripción

    Adverse Experiences

    Alias
    UMLS CUI-1
    C0877248
    Did the patient have any adverse experiences? (If yes, please record on AE page)
    Descripción

    If yes, please record on AE page

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    (Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
    Descripción

    (Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0032831
    UMLS CUI [1,3]
    C0065234
    (Note; only Day 7) If No to previous question please explain
    Descripción

    (Note; only Day 7) If No to previous question please explain

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0681841
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    Similar models

    Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

    1 formularios
    1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
      1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Site Number
    Item
    Site Number:
    integer
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Laboratory Results Baseline
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Hematology Date
    Item
    Hematology Date
    date
    C0474523 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Lab Nr.
    Item
    Lab # (Worksheet B)
    text
    C1300638 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    WBC
    Item
    WBC
    float
    C0023508 (UMLS CUI [1])
    RBC
    Item
    RBC
    float
    C0014772 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    Platelets
    Item
    Platelets
    float
    C0005821 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0200633 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    float
    C0200635 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes
    float
    C0200637 (UMLS CUI [1])
    Eosinophils
    Item
    Eosinophils
    float
    C0200638 (UMLS CUI [1])
    Basophils
    Item
    Basophils
    float
    C0200641 (UMLS CUI [1])
    Other Differential
    Item
    Other Differential
    text
    C0022885 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    ANC-Absolute Neutrophile Count
    Item
    Absolute Neutrophile Count-ANC (10³/mm³)
    float
    C0948762 (UMLS CUI [1])
    Item Group
    Laboratory Tests-Blood Chemistry
    C1254595 (UMLS CUI-1)
    C0005774 (UMLS CUI-2)
    Chemistry Date
    Item
    Chemistry Date
    date
    C0011008 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    Lab Nr.
    Item
    Lab # (Worksheet B)
    text
    C1300638 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Chloride
    Item
    Chloride
    float
    C0201952 (UMLS CUI [1])
    BUN
    Item
    BUN
    float
    C0005845 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    AST (SGOT)
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    ALT (SGPT)
    Item
    ALT (SGPT)
    float
    C0201836 (UMLS CUI [1])
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    C0201850 (UMLS CUI [1])
    LDH
    Item
    LDH
    float
    C0202113 (UMLS CUI [1])
    Total Bilirubin
    Item
    Total Bilirubin
    float
    C0201913 (UMLS CUI [1])
    TSH
    Item
    TSH
    float
    C0202230 (UMLS CUI [1])
    Total T3
    Item
    Total T3
    float
    C0428419 (UMLS CUI [1])
    Free T4
    Item
    Free T4
    float
    C0202225 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    N/A
    Item
    N/A
    boolean
    C1272460 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Item
    Sample
    integer
    C0200345 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Sample
    Code List
    Sample
    CL Item
    Urine (1)
    CL Item
    Serum (2)
    Item
    Result
    integer
    C0427777 (UMLS CUI [1])
    Result
    Code List
    Result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Beta-2 Microglobulin (Serum)
    C0005149 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    C0005149 (UMLS CUI [1,3])
    Result
    Item
    Result
    text
    C1274040 (UMLS CUI [1,1])
    C0005149 (UMLS CUI [1,2])
    Item Group
    Infusion Record Dosimetric Dose - Day 0 and Day 7
    C0574032 (UMLS CUI-1)
    C2094191 (UMLS CUI-2)
    Date Administered
    Item
    Date Administered
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Baseline HAMA (human antimurine antibody)
    C1291910 (UMLS CUI-1)
    C1442488 (UMLS CUI-2)
    Baseline HAMA date
    Item
    Baseline HAMA date
    date
    C1291910 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Baseline HAMA Result
    integer
    C1442488 (UMLS CUI [1,1])
    C1291910 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Baseline HAMA Result
    Code List
    Baseline HAMA Result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Dosimetric Dose
    C2094191 (UMLS CUI-1)
    Time Started (cold)
    Item
    Time Started (24 hour clock) (cold)
    time
    C1301880 (UMLS CUI [1])
    Time Finished (24 hour clock) (cold)
    Item
    Time Finished (24 hour clock) (cold)
    time
    C1522314 (UMLS CUI [1])
    Time Started (24 hour clock) (cold flush)
    Item
    Time Started (24 hour clock) (cold flush)
    time
    C1301880 (UMLS CUI [1])
    Time Finished (24 hour clock) (cold flush)
    Item
    Time Finished (24 hour clock) (cold flush)
    time
    C1522314 (UMLS CUI [1])
    Time Started (24 hour clock) (hot)
    Item
    Time Started (24 hour clock) (hot)
    time
    C1301880 (UMLS CUI [1])
    Time Finished (24 hour clock) (hot)
    Item
    Time Finished (24 hour clock) (hot)
    time
    C1522314 (UMLS CUI [1])
    Time Started (24 hour clock) (hot flush)
    Item
    Time Started (24 hour clock) (hot flush)
    time
    C1301880 (UMLS CUI [1])
    Time Finished (24 hour clock) (hot flush)
    Item
    Time Finished (24 hour clock) (hot flush)
    time
    C1522314 (UMLS CUI [1])
    Item Group
    Anti-B1 Dose
    C0768182 (UMLS CUI-1)
    C3174092 (UMLS CUI-2)
    Anti-B1 Dose (cold dose)
    Item
    Anti-B1 Dose (cold dose)
    float
    C0768182 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Lot number of Anti-B1 (cold)
    Item
    Lot number of Anti-B1 (cold)
    text
    C1115660 (UMLS CUI [1,1])
    C0768182 (UMLS CUI [1,2])
    Anti-B1 Dose (hot dose)
    Item
    Anti-B1 Dose (hot dose)
    float
    C0768182 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Lot number of Anti-B1 (hot)
    Item
    Lot number of Anti-B1 (hot)
    text
    C1115660 (UMLS CUI [1,1])
    C0768182 (UMLS CUI [1,2])
    Iodine-131 Anti-B1 (prescribed)
    Item
    Iodine-131 Anti-B1 (prescribed)
    text
    C0768182 (UMLS CUI [1])
    Lot Number (Nordion)
    Item
    Lot Number (Nordion)
    text
    C1115660 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Item Group
    Infusion Rate
    C2964135 (UMLS CUI-1)
    Infusion rate need to be adjusted?
    Item
    Did infusion rate need to be adjusted?
    boolean
    C2964135 (UMLS CUI [1,1])
    C2826232 (UMLS CUI [1,2])
    Item
    If yes, was infusion rate
    integer
    C2964135 (UMLS CUI [1,1])
    C2826232 (UMLS CUI [1,2])
    If yes, was infusion rate
    Code List
    If yes, was infusion rate
    CL Item
    Decreased by 1/2 (1)
    CL Item
    discontinued (2)
    CL Item
    other (3)
    Item
    If the infusion rate was adjusted, was it for (check all that apply)
    integer
    C2964135 (UMLS CUI [1,1])
    C2826232 (UMLS CUI [1,2])
    If the infusion rate was adjusted, was it for (check all that apply)
    Code List
    If the infusion rate was adjusted, was it for (check all that apply)
    CL Item
    low SBP (1)
    CL Item
    rigors (2)
    CL Item
    fever (3)
    CL Item
    mucosal congestion/edema (4)
    CL Item
    other (5)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Time (24 hr)
    Item
    Time (24 hr)
    time
    C0040223 (UMLS CUI [1])
    BP
    Item
    Blood Pressure (mmhg)
    text
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temp
    Item
    Temp. (C)
    float
    C0005903 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Adverse Experiences
    C0877248 (UMLS CUI-1)
    Did the patient have any adverse experiences?
    Item
    Did the patient have any adverse experiences? (If yes, please record on AE page)
    boolean
    C0877248 (UMLS CUI [1])
    (Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide
    Item
    (Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0032831 (UMLS CUI [1,2])
    C0065234 (UMLS CUI [1,3])
    (Note; only Day 7) If No to previous question please explain
    Item
    (Note; only Day 7) If No to previous question please explain
    text
    C0947611 (UMLS CUI [1,1])
    C0681841 (UMLS CUI [1,2])
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