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25402

Descrizione

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Keywords

versioni (2)
  1. 19/08/17 19/08/17 -
  2. 03/09/17 03/09/17 -
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3 settembre 2017

DOI

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Creative Commons BY-NC 3.0
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

    Inglese

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

    1 moduli  
    Check for study continuation
    Descrizione

    Check for study continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0042210
    Did the subject return for visit 2?
    Descrizione

    study continuation

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0008972
    UMLS CUI [1,2]
    C0805733
    Why didn't the subject return to visit 2?
    Descrizione

    Please tick the ONE most appropriate reason and skip the following pages of this visit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348568
    SAE No
    Descrizione

    Please specify number of SAE if that is the reason, why subject didn't return to visit 2.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Please specify unsolicited AE No
    Descrizione

    number of unsolicited adverse event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    solicited AE code
    Descrizione

    solicited AE code

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Please specify 'other' most appropriate category for not returning to visit 2.
    Descrizione

    e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2348568
    Please tick who took the decision
    Descrizione

    decision for study withdrawal

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0679006
    Laboratory tests
    Descrizione

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken?
    Descrizione

    Blood sample

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0005834
    Date blood sample taken
    Descrizione

    Please complete only if different from visit date

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Household exposure
    Descrizione

    Household exposure

    Alias
    UMLS CUI-1
    C0332157
    UMLS CUI-2
    C0020052
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
    Descrizione

    Exposure in household to varicella/zoster

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0332157
    UMLS CUI [1,3]
    C0020052
    UMLS CUI [2,1]
    C0740380
    UMLS CUI [2,2]
    C0332157
    UMLS CUI [2,3]
    C0020052
    Household exposure number
    Descrizione

    Household exposure number

    Alias
    UMLS CUI-1
    C0332157
    UMLS CUI-2
    C0020052
    UMLS CUI-3
    C0449788
    Household Exposure No
    Descrizione

    Household Exposure No

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0020052
    UMLS CUI [1,3]
    C0449788
    Date of onset exposure
    Descrizione

    Date of onset exposure

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0332157
    Type of exposure
    Descrizione

    Type of exposure

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0332157
    Varicella or zoster
    Descrizione

    Varicella or zoster

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-3
    C0740380
    Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
    Descrizione

    if 'yes', please complete the Varicella or Zoster Case section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0740380
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0008049
    How many episodes?
    Descrizione

    Number of episodes of varicella/zoster signs and symptoms

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0740380
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0008049
    Vaccine administration
    Descrizione

    Vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    Pre-Vaccination temperature
    Descrizione

    Pre-Vaccination temperature

    Tipo di dati

    float

    Unità di misura
    • degree Celsius
    Alias
    UMLS CUI [1]
    C0005903
    degree Celsius
    Route
    Descrizione

    anatomic site Temperature taken

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1515974
    Vaccine administration
    Descrizione

    Vaccine administration

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2368628
    Replacement vial
    Descrizione

    Replacement vial

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    UMLS CUI [1,3]
    C0600091
    Wrong vial number
    Descrizione

    Wrong vial number

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C3827420
    Has the study vaccine been administered according to the Protocol?
    Descrizione

    Protocol: Side: Left Site: Upper arm (Deltoid) Route: S.C.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    Side (vaccine administered)
    Descrizione

    Only answer if vaccine wasn't administered according to protocol.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0444532
    UMLS CUI [1,3]
    C0443246
    Site (vaccine administered)
    Descrizione

    Only answer if vaccine wasn't administered according to protocol.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    Route (vaccine administered)
    Descrizione

    Only answer if vaccine wasn't administered according to protocol.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0013153
    Comments (on vaccine administration)
    Descrizione

    Comments on vaccine administration

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0947611
    Date of vaccination
    Descrizione

    fill in only if different from visit date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C4301990
    Why was the vaccine not administered?
    Descrizione

    Please tick the ONE most appropriate category for non administration

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    SAE No
    Descrizione

    Please specify number of SAE if that is the reason, why vaccine wasn't administered.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Please specify unsolicited AE No
    Descrizione

    number of unsolicited adverse event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Please specify 'other' most appropriate category for non administration.
    Descrizione

    e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2368628
    Unsolicited adverse event
    Descrizione

    Unsolicited adverse event

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0042196
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    Descrizione

    non-serious unsolicited adverse event

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231291
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0231291
    Solicited adverse events - Local symptoms
    Descrizione

    Solicited adverse events - Local symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    UMLS CUI-3
    C0042196
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Descrizione

    If Yes is ticked, please complete all following items.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0851536
    UMLS CUI [1,2]
    C0037088
    Redness
    Descrizione

    Administration site erythema

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3805283
    Size (of redness at administration site) Day 0
    Descrizione

    Size of erythema at administration site Day 0

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 1
    Descrizione

    Size of erythema at administration site Day 1

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 2
    Descrizione

    Size of erythema at administration site Day 2

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 3
    Descrizione

    Size of erythema at administration site Day 3

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Ongoing after Day 3?
    Descrizione

    Erythema ongoing after day 3

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Descrizione

    Date of last day of symptoms

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0332575
    UMLS CUI [1,3]
    C2700396
    Swelling
    Descrizione

    Administration site swelling

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3854415
    Size (of swelling at administration site) Day 0
    Descrizione

    Size of swelling at administration site Day 0

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 1
    Descrizione

    Size of swelling at administration site Day 1

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 2
    Descrizione

    Size of swelling at administration site Day 2

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 3
    Descrizione

    Size of swelling at administration site Day 3

    Tipo di dati

    integer

    Unità di misura
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Ongoing after day 3?
    Descrizione

    Swelling ongoing after day 3

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Descrizione

    Date of last day of symptoms

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C2700396
    Pain
    Descrizione

    Administration site pain

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0521491
    Intensity (of pain at administration site) Day 0
    Descrizione

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 1
    Descrizione

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 2
    Descrizione

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 3
    Descrizione

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Ongoing after day 3?
    Descrizione

    Pain ongoing after day 3

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Descrizione

    Date of last day of symptoms

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C2700396
    Solicited adverse events - General symptoms
    Descrizione

    Solicited adverse events - General symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0877248
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
    Descrizione

    If Yes is ticked, please complete all following items.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C2368628
    Fever
    Descrizione

    ≥37.5 °C axillary/≥38.0 °C rectal route If yes, please complete the Temperature section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C2368628
    General rash / exanthema
    Descrizione

    excluding varicella / zoster If yes, please complete the Rash / Exanthema section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C2368628
    Parotid / salivary gland swelling
    Descrizione

    If yes, please complete the Parotid / Salivary Gland Swelling section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C2368628
    Febrile convulsions – suspected signs of meningism
    Descrizione

    If yes, please complete the Febrile Convulsions – Suspected Signs of Meningism section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [2,1]
    C0025287
    UMLS CUI [2,2]
    C2368628
    Varicella / zoster
    Descrizione

    If yes, please complete the Varicella / Zoster section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [2,1]
    C0740380
    UMLS CUI [2,2]
    C2368628
    Temperature
    Descrizione

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Route
    Descrizione

    Direct measurement of axillary/ rectal temperature within 15 days post-vaccination 1. Only ONE route of temperature measurement should be used consistently for a given subject. Fever: Axillary: > 37.5°C Rectal: > 38.0°C

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1515974
    Temperature
    Descrizione

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Episode No
    Descrizione

    Day 0 - 42

    Tipo di dati

    integer

    Temperature
    Descrizione

    Temperature

    Tipo di dati

    float

    Unità di misura
    • Degree Celsius
    Alias
    UMLS CUI [1]
    C0039476
    Degree Celsius
    Not taken (Temperature)
    Descrizione

    Temperature not taken

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0039476
    Causality
    Descrizione

    Only fill in if fever.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C3641099
    UMLS CUI [1,3]
    C2368628
    Medically attended Visit?
    Descrizione

    Medically attended Visit?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
    Ritorna all'inizio della pagina

    Similar models

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Check for study continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    Item
    Did the subject return for visit 2?
    integer
    C0008972 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    study continuation
    Code List
    Did the subject return for visit 2?
    CL Item
    Yes, please complete the next pages. (1)
    CL Item
    No (2)
    Item
    Why didn't the subject return to visit 2?
    text
    C2348568 (UMLS CUI [1])
    Why didn't the subject return to visit 2?
    Code List
    Why didn't the subject return to visit 2?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
    Number of serious adverse event
    Item
    SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    number of unsolicited adverse event
    Item
    Please specify unsolicited AE No
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    solicited AE code
    Item
    solicited AE code
    text
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    specify other reason
    Item
    Please specify 'other' most appropriate category for not returning to visit 2.
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Item
    Please tick who took the decision
    text
    C2348568 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    decision for study withdrawal
    Code List
    Please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents / Guardians (P)
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Item
    Has a blood sample been taken?
    integer
    C0005834 (UMLS CUI [1])
    Blood sample
    Code List
    Has a blood sample been taken?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Date blood sample taken
    Item
    Date blood sample taken
    boolean
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Household exposure
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    Exposure in household to varicella/zoster
    Item
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
    boolean
    C0008049 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    C0020052 (UMLS CUI [1,3])
    C0740380 (UMLS CUI [2,1])
    C0332157 (UMLS CUI [2,2])
    C0020052 (UMLS CUI [2,3])
    Item Group
    Household exposure number
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    C0449788 (UMLS CUI-3)
    Household Exposure No
    Item
    Household Exposure No
    integer
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Date of onset exposure
    Item
    Date of onset exposure
    date
    C0574845 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    Item
    Type of exposure
    integer
    C0332157 (UMLS CUI [1])
    Type of exposure
    Code List
    Type of exposure
    CL Item
    Varicella (1)
    CL Item
    Zoster (2)
    Item Group
    Varicella or zoster
    C0008049 (UMLS CUI-1)
    C0740380 (UMLS CUI-3)
    signs or symptoms of varicella or zoster
    Item
    Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
    boolean
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    Number of episodes of varicella/zoster signs and symptoms
    Item
    How many episodes?
    integer
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    Item Group
    Vaccine administration
    C2368628 (UMLS CUI-1)
    Pre-Vaccination temperature
    Item
    Pre-Vaccination temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Route
    text
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    anatomic site Temperature taken
    Code List
    Route
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item
    Vaccine administration
    text
    C2368628 (UMLS CUI [1])
    Vaccine administration
    Code List
    Vaccine administration
    CL Item
    Study Vaccine (S)
    CL Item
    Replacement vial (R)
    CL Item
    Wrong vial number (W)
    CL Item
    Not administered (N)
    Replacement vial
    Item
    Replacement vial
    text
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Wrong vial number
    Item
    Wrong vial number
    text
    C0184301 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C3827420 (UMLS CUI [1,3])
    vaccine administered according to protocol
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Item
    Side (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C0444532 (UMLS CUI [1,2])
    C0443246 (UMLS CUI [1,3])
    Side (vaccine administered)
    Code List
    Side (vaccine administered)
    CL Item
    Right (R)
    CL Item
    Left (L)
    Item
    Site (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Site (vaccine administered)
    Code List
    Site (vaccine administered)
    CL Item
    Thigh (3)
    CL Item
    Buttock (6)
    CL Item
    Upper arm (Deltoid) (10)
    CL Item
    Lower arm (11)
    Item
    Route (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Route (vaccine administered)
    Code List
    Route (vaccine administered)
    CL Item
    i.m. (IM)
    CL Item
    s.c. (SC)
    Comments on vaccine administration
    Item
    Comments (on vaccine administration)
    text
    C2368628 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Date of vaccination
    Item
    Date of vaccination
    date
    C4301990 (UMLS CUI [1])
    Item
    Why was the vaccine not administered?
    text
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Why was the vaccine not administered?
    Code List
    Why was the vaccine not administered?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
    Number of serious adverse event
    Item
    SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    number of unsolicited adverse event
    Item
    Please specify unsolicited AE No
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    specify other reason
    Item
    Please specify 'other' most appropriate category for non administration.
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [1,3])
    Item Group
    Unsolicited adverse event
    C0877248 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    text
    C1519255 (UMLS CUI [1,1])
    C0231291 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0231291 (UMLS CUI [2,2])
    non-serious unsolicited adverse event
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
    Item Group
    Solicited adverse events - Local symptoms
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    C0042196 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    text
    C0851536 (UMLS CUI [1,1])
    C0037088 (UMLS CUI [1,2])
    signs or symptoms at administration site
    Code List
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    CL Item
    Information not available (U)
    CL Item
    No vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Administration site erythema
    Item
    Redness
    boolean
    C3805283 (UMLS CUI [1])
    Size of erythema at administration site Day 0
    Item
    Size (of redness at administration site) Day 0
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 1
    Item
    Size (of redness at administration site) Day 1
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 2
    Item
    Size (of redness at administration site) Day 2
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 3
    Item
    Size (of redness at administration site) Day 3
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Erythema ongoing after day 3
    Item
    Ongoing after Day 3?
    boolean
    C3805283 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Administration site swelling
    Item
    Swelling
    boolean
    C3854415 (UMLS CUI [1])
    Size of swelling at administration site Day 0
    Item
    Size (of swelling at administration site) Day 0
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 1
    Item
    Size (of swelling at administration site) Day 1
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 2
    Item
    Size (of swelling at administration site) Day 2
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 3
    Item
    Size (of swelling at administration site) Day 3
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling ongoing after day 3
    Item
    Ongoing after day 3?
    boolean
    C3854415 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Administration site pain
    Item
    Pain
    boolean
    C0521491 (UMLS CUI [1])
    Intensity of pain at administration site Day 0
    Item
    Intensity (of pain at administration site) Day 0
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 1
    Item
    Intensity (of pain at administration site) Day 1
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 2
    Item
    Intensity (of pain at administration site) Day 2
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 3
    Item
    Intensity (of pain at administration site) Day 3
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Pain ongoing after day 3
    Item
    Ongoing after day 3?
    boolean
    C0521491 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Item Group
    Solicited adverse events - General symptoms
    C1457887 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
    text
    C0037088 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    undefined item
    Code List
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Fever after vaccine administration
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    General rash / exanthema after vaccine administration
    Item
    General rash / exanthema
    boolean
    C0015230 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    salivary gland swelling
    Item
    Parotid / salivary gland swelling
    boolean
    C0240925 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Febrile convulsions or suspected signs of meningism after vaccine administration
    Item
    Febrile convulsions – suspected signs of meningism
    boolean
    C0009952 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0025287 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    Varicella or Varicella zoster after vaccine administration
    Item
    Varicella / zoster
    boolean
    C0008049 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0740380 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Item
    Route
    text
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    temperature route
    Code List
    Route
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Episode No
    Item
    Episode No
    integer
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Temperature not taken
    Item
    Not taken (Temperature)
    boolean
    C0039476 (UMLS CUI [1])
    Causality with vaccination fever
    Item
    Causality
    boolean
    C0015967 (UMLS CUI [1,1])
    C3641099 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [1,3])
    Medically attended Visit?
    Item
    Medically attended Visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
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