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35766

Description

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 general medical history/ physical examination form. It has to be filled in for screening.

Link

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

Keywords

Versions (2)
  1. 3/20/19 3/20/19 -
  2. 3/21/19 3/21/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

    English

    General medical history/ physical examination

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Visit
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    General Medical History/ Physical Examination
    Description

    General Medical History/ Physical Examination

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
    Description

    If you tick yes, please give diagnosis and tick appropriate Past/Current box(es).

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    MedDRA SYSTEM ORGAN CLASS
    Description

    MedDRA SYSTEM ORGAN CLASS

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347091 (MedDRA System Organ Class)
    General Medical History/ Physical examination, diagnosis
    Description

    Please report medication(s) as specified in the protocol and fill in the Medication section.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,3]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Disease, signs and symptoms
    Description

    Disease, signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
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    Similar models

    General medical history/ physical examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 Group
    General Medical History/ Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Item
    Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
    text
    C0012634 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Medical condition, signs and symptoms
    Code List
    Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    MedDRA SYSTEM ORGAN CLASS
    integer
    C2347091 (UMLS CUI [1])
    Physical examination
    Code List
    MedDRA SYSTEM ORGAN CLASS
    CL Item
    Skin and subcutaneous tissue (1)
    CL Item
    Musculoskeletal and connective tissue (2)
    CL Item
    Cardiac (3)
    CL Item
    Vascular (4)
    CL Item
    Respiratory, thoracic and mediastinal (5)
    CL Item
    Gastrointestinal (6)
    CL Item
    Hepatobiliary (7)
    CL Item
    Renal and urinary (8)
    CL Item
    Nervous system (9)
    CL Item
    Eye (10)
    CL Item
    Ear and labyrinth (11)
    CL Item
    Endocrine (12)
    CL Item
    Metabolism and nutrition (13)
    CL Item
    Blood and lymphatic system (14)
    CL Item
    Immune system (incl allergies, autoimmune disorders) (15)
    CL Item
    Infections and infestations (16)
    CL Item
    Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
    CL Item
    Surgical and medical procedures (18)
    CL Item
    Other (99)
    General Medical History/ Physical examination, diagnosis
    Item
    General Medical History/ Physical examination, diagnosis
    text
    C0262926 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [1,3])
    Item
    Disease, signs and symptoms
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0449438 (UMLS CUI [2,2])
    Examination status
    Code List
    Disease, signs and symptoms
    CL Item
    Past (1)
    CL Item
    Current (2)
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