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Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Lymph node examination form. It has to be filled in for screening and for all Visits (Visit 1-6).

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Stichworte

Versionen (1)
  1. 20.03.19 20.03.19 -
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GlaxoSmithKline

Hochgeladen am

20. März 2019

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    Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

    Englisch

    Lymph node examination

    1 Formulare  
    1. StudyEvent: ODM
      1. Lymph node examination
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Visit type
    Beschreibung

    Visit type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Lymph node examination (for axillary and supraclavicular)
    Beschreibung

    Lymph node examination (for axillary and supraclavicular)

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0729594
    UMLS CUI-3
    C0229730
    Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
    Beschreibung

    Axillary and supraclavicular lymph nodes

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0729594
    UMLS CUI [2]
    C0229730
    If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
    Beschreibung

    Axillary or supraclavicular lymphadenopathy

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0578735
    UMLS CUI [2,1]
    C0229730
    UMLS CUI [2,2]
    C0497156
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
    Beschreibung

    Lymphadenopathy results, anatomic structure

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0497156
    UMLS CUI [1,2]
    C0700276
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
    Beschreibung

    Lymphadenopathy results, anatomic Side

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0497156
    UMLS CUI [1,2]
    C1515974
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
    Beschreibung

    Grade definition: Grade 0 (none): No palpable nodes, or all nodes < 1 cm (pea-sized), mobile, and non-tender Grade 1 (mild): At least one node > 1 cm (pea-sized) but less than 2.5 cm (cherry-sized), but mobile and non-tender or tender only with firm pressure Grade 2 (moderate): At least one node >= 2.5 cm (cherry-sized) or tender to light touch or spontaneously reported as painful, but not causing significant limitation of normal everyday activities Grade 3 (severe): At least one node that is tender to light touch or spontaneously reported as painful AND causing significant limitation of normal everyday activities. Any one of palpable fluctuance or heat, fixation to underlying tissues, or visible erythema. If ulceration or drainage is present, must also report as SAE.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0497156
    UMLS CUI [1,2]
    C1274040
    Lymph node examination (for other lymph nodes localisation)
    Beschreibung

    Lymph node examination (for other lymph nodes localisation)

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0205394
    UMLS CUI-3
    C0024204
    UMLS CUI-4
    C0475264
    Was an examination of lymph nodes at any other site performed based on investigator judgement?
    Beschreibung

    Other lymph nodes

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0024204
    If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
    Beschreibung

    Other lymphadenopathy

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0497156
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
    Beschreibung

    Other Lymphadenopathy results, anatomic structure

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0497156
    UMLS CUI [1,3]
    C0700276
    If other anatomic structure, please specify
    Beschreibung

    Other anatomic structure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0700276
    UMLS CUI [1,2]
    C0205394
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
    Beschreibung

    Other Lymphadenopathy results, anatomic Site

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0497156
    UMLS CUI [1,3]
    C1515974
    If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
    Beschreibung

    Grade definition: Grade 0 (none): No palpable nodes, or all nodes < 1 cm (pea-sized), mobile, and non-tender Grade 1 (mild): At least one node > 1 cm (pea-sized) but less than 2.5 cm (cherry-sized), but mobile and non-tender or tender only with firm pressure Grade 2 (moderate): At least one node >= 2.5 cm (cherry-sized) or tender to light touch or spontaneously reported as painful, but not causing significant limitation of normal everyday activities Grade 3 (severe): At least one node that is tender to light touch or spontaneously reported as painful AND causing significant limitation of normal everyday activities. Any one of palpable fluctuance or heat, fixation to underlying tissues, or visible erythema. If ulceration or drainage is present, must also report as SAE.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0497156
    UMLS CUI [1,3]
    C1274040
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Lymph node examination

    1 Formulare
    1. StudyEvent: ODM
      1. Lymph node examination
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C0011008 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    Visit 1 (2)
    CL Item
    Visit 2 (3)
    CL Item
    Visit 3 (4)
    CL Item
    Visit 4 (5)
    CL Item
    Visit 5 (6)
    CL Item
    Visit 6 (7)
    Item Group
    Lymph node examination (for axillary and supraclavicular)
    C0031809 (UMLS CUI-1)
    C0729594 (UMLS CUI-2)
    C0229730 (UMLS CUI-3)
    Item
    Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
    text
    C0729594 (UMLS CUI [1])
    C0229730 (UMLS CUI [2])
    Axillary and supraclavicular lymph nodes
    Code List
    Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
    text
    C0578735 (UMLS CUI [1])
    C0229730 (UMLS CUI [2,1])
    C0497156 (UMLS CUI [2,2])
    Axillary or supraclavicular lymphadenopathy
    Code List
    If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
    integer
    C0497156 (UMLS CUI [1,1])
    C0700276 (UMLS CUI [1,2])
    Lymphadenopathy results, anatomic structure
    Code List
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
    CL Item
    Axillary (1)
    CL Item
    Supraclavicular (2)
    Item
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
    integer
    C0497156 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Lymphadenopathy results, anatomic structure
    Code List
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
    integer
    C0497156 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Lymphadenopathy results, Grade
    Code List
    If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    Item Group
    Lymph node examination (for other lymph nodes localisation)
    C0031809 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    C0024204 (UMLS CUI-3)
    C0475264 (UMLS CUI-4)
    Item
    Was an examination of lymph nodes at any other site performed based on investigator judgement?
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0024204 (UMLS CUI [1,3])
    Other lymph nodes
    Code List
    Was an examination of lymph nodes at any other site performed based on investigator judgement?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
    text
    C0205394 (UMLS CUI [1,1])
    C0497156 (UMLS CUI [1,2])
    Axillary or supraclavicular lymphadenopathy
    Code List
    If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
    integer
    C0205394 (UMLS CUI [1,1])
    C0497156 (UMLS CUI [1,2])
    C0700276 (UMLS CUI [1,3])
    Lymphadenopathy results, anatomic structure
    Code List
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
    CL Item
    Cervical (1)
    CL Item
    Inguinal (2)
    CL Item
    Occipital (3)
    CL Item
    Submandibular (4)
    CL Item
    Other  (5)
    Other anatomic structure
    Item
    If other anatomic structure, please specify
    text
    C0700276 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
    integer
    C0205394 (UMLS CUI [1,1])
    C0497156 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [1,3])
    Lymphadenopathy results, anatomic structure
    Code List
    If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
    integer
    C0205394 (UMLS CUI [1,1])
    C0497156 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Lymphadenopathy results, Grade
    Code List
    If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    Zum Seitenanfang zurückkehren 

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