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22127

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Study part: Study termination physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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  1. 5/20/17 5/20/17 -
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    STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer

    English

    STUDY TERMINATION PHYSICAL EXAMINATION

    1 forms  
    PHYSICAL EXAMINATION
    Description

    PHYSICAL EXAMINATION

    Alias
    UMLS CUI-1
    C0031809
    PATIENT INT.
    Description

    Patient initial

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    PATIENT NUMBER
    Description

    Patient id

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    DATE OF EXAMINATION
    Description

    DATE OF EXAMINATION

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    WEIGHT
    Description

    WEIGHT

    Data type

    float

    Measurement units
    • lb
    Alias
    UMLS CUI [1]
    C0005910
    lb
    WEIGHT
    Description

    WEIGHT

    Data type

    float

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

    TEMPERATURE

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    TEMPERATURE
    Description

    TEMPERATURE

    Data type

    float

    Measurement units
    • °F
    Alias
    UMLS CUI [1]
    C0039476
    °F
    SYSTOLIC BLOOD PRESSURE
    Description

    SYSTOLIC BLOOD PRESSURE

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    DIASTOLIC BLOOD PRESSURE
    Description

    Diastolic blood pressure

    Data type

    integer

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

    Heart rate

    Data type

    integer

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

    respiratory rate

    Data type

    integer

    Measurement units
    • resp/min
    Alias
    UMLS CUI [1]
    C0231832
    resp/min
    1. HEENT
    Description

    HEAD.EARS. EYES. NOSE. THROAT

    Data type

    text

    Alias
    UMLS CUI [1]
    C1512338
    1. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    1. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    2. NECK
    Description

    NECK

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027530
    2. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    2. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    3. BREASTS
    Description

    BREASTS

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199850
    3. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    3. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    4. CHEST
    Description

    CHEST

    Data type

    text

    Alias
    UMLS CUI [1]
    C0817096
    4. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    4. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    5. LYMPH NODES
    Description

    LYMPH NODES

    Data type

    text

    Alias
    UMLS CUI [1]
    C0024204
    5. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    5. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    6. HEART
    Description

    HEART

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018787
    6. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    6. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    7. ABDOMEN
    Description

    ABDOMEN

    Data type

    text

    Alias
    UMLS CUI [1]
    C0000726
    7. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    7. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    8. PELVIC
    Description

    PELVIC

    Data type

    text

    Alias
    UMLS CUI [1]
    C0030797
    8. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    8. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    9. RECTAL
    Description

    RECTAL

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199900
    9. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    9. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    10. EXTREMITIES
    Description

    EXTREMITIES

    Data type

    text

    Alias
    UMLS CUI [1]
    C0436150
    10. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    10. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    11. NEUROLOGICAL
    Description

    NEUROLOGICAL

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027853
    11. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    11. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
    12. SKIN
    Description

    SKIN

    Data type

    text

    Alias
    UMLS CUI [1]
    C1123023
    12. IF ABNORMAL, DESCRIBE:
    Description

    description

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    12. FINDING IS AN AE?
    Description

    finding adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0877248
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    Similar models

    STUDY TERMINATION PHYSICAL EXAMINATION

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    PHYSICAL EXAMINATION
    C0031809 (UMLS CUI-1)
    Patient initial
    Item
    PATIENT INT.
    text
    C2986440 (UMLS CUI [1])
    Patient id
    Item
    PATIENT NUMBER
    integer
    C2348585 (UMLS CUI [1])
    DATE OF EXAMINATION
    Item
    DATE OF EXAMINATION
    date
    C2826643 (UMLS CUI [1])
    WEIGHT
    Item
    WEIGHT
    float
    C0005910 (UMLS CUI [1])
    WEIGHT
    Item
    WEIGHT
    float
    C0005910 (UMLS CUI [1])
    TEMPERATURE
    Item
    TEMPERATURE
    float
    C0039476 (UMLS CUI [1])
    TEMPERATURE
    Item
    TEMPERATURE
    float
    C0039476 (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])
    Heart rate
    Item
    HR
    integer
    C0018810 (UMLS CUI [1])
    respiratory rate
    Item
    RR
    integer
    C0231832 (UMLS CUI [1])
    Item
    1. HEENT
    text
    C1512338 (UMLS CUI [1])
    HEENT
    Code List
    1. HEENT
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    1. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    1. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    2. NECK
    text
    C0027530 (UMLS CUI [1])
    HEENT
    Code List
    2. NECK
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    2. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    2. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    3. BREASTS
    text
    C0199850 (UMLS CUI [1])
    HEENT
    Code List
    3. BREASTS
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    3. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    3. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    4. CHEST
    text
    C0817096 (UMLS CUI [1])
    HEENT
    Code List
    4. CHEST
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    4. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    4. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    5. LYMPH NODES
    text
    C0024204 (UMLS CUI [1])
    HEENT
    Code List
    5. LYMPH NODES
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    5. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    5. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    6. HEART
    text
    C0018787 (UMLS CUI [1])
    HEENT
    Code List
    6. HEART
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    6. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    6. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    7. ABDOMEN
    text
    C0000726 (UMLS CUI [1])
    HEENT
    Code List
    7. ABDOMEN
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    7. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    7. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    8. PELVIC
    text
    C0030797 (UMLS CUI [1])
    HEENT
    Code List
    8. PELVIC
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    8. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    8. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    9. RECTAL
    text
    C0199900 (UMLS CUI [1])
    HEENT
    Code List
    9. RECTAL
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    9. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    9. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    10. EXTREMITIES
    text
    C0436150 (UMLS CUI [1])
    HEENT
    Code List
    10. EXTREMITIES
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    10. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    10. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    11. NEUROLOGICAL
    text
    C0027853 (UMLS CUI [1])
    HEENT
    Code List
    11. NEUROLOGICAL
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    11. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    11. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    12. SKIN
    text
    C1123023 (UMLS CUI [1])
    HEENT
    Code List
    12. SKIN
    CL Item
    NORMAL  (1)
    CL Item
    ABNORMAL  (2)
    CL Item
    NOT DONE (3)
    description
    Item
    12. IF ABNORMAL, DESCRIBE:
    text
    C0678257 (UMLS CUI [1])
    finding adverse event
    Item
    12. FINDING IS AN AE?
    boolean
    C0243095 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
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