0 Evaluaciones
ID

25355

Descripción

Phase A - Year 1 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 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

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Versiones (1)
  1. 02/09/2017 02/09/2017 -
Titular de derechos de autor

glaxoSmithKline

Subido en

2 septembre 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Phase A - Year 1 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    Inglés

    Phase A - Year 1 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 formularios  
    Concomitant Vaccination
    Descripción

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered between Visit 3 and Visit 4?
    Descripción

    If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant vaccination
    Descripción

    Concomitant vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade / (Generic) Name
    Descripción

    Trade name of vaccine

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0042196
    Route
    Descripción

    Administration route of vaccine

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Administration date
    Descripción

    Vaccine administration date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    Medication
    Descripción

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered between Visit 3 and Visit 4 according to protocol?
    Descripción

    Medication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Medication
    Descripción

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade / Generic name
    Descripción

    Trade name of medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0013227
    Medical indication
    Descripción

    Medical indication for medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Prophylactic
    Descripción

    Prophylactic medication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0420172
    Total daily dose
    Descripción

    Total daily dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Route
    Descripción

    Route of administration

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Descripción

    Start Date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End date
    Descripción

    End Date of Medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuous medication
    Descripción

    Medication continuing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Occurrence of serious adverse event
    Descripción

    Occurrence of serious adverse event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
    Descripción

    Serious adverse event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Specify total number of SAE's
    Descripción

    Only answer if you chose 'yes'a s previous answer.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Status of treatment blind
    Descripción

    Status of treatment blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken between Visit 3 and Visit 4?
    Descripción

    treatment blind broken

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C0449438
    Complete date treatment blind was broken.
    Descripción

    Date treatment blind broken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason for breaking treatment blind
    Descripción

    Reason treatment blind broken

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Elimination criteria
    Descripción

    Elimination criteria

    Alias
    UMLS CUI-1
    C0680251
    Did any elimination criteria become applicable between Visit 3 and Visit 4?
    Descripción

    Elimination criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Specify elimination criteria
    Descripción

    Only answer if you chose 'yes' as previous answer.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1521902
    Was the subject withdrawn from the study "Phase A year 1"?
    Descripción

    study subject participation status withdrawn

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0422727
    Please tick the ONE most appropriate category for withdrawal.
    Descripción

    Reason for withdrawal

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Please specify SAE No
    Descripción

    Number of serious adverse events

    Tipo de datos

    integer

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

    Number of unsolicited adverse events

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Please specify solicited AE code
    Descripción

    solicited adverse event code

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C1521902
    Please specify protocol violation
    Descripción

    specify protocol violation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C1521902
    Please specify other reason for study withdrawal
    Descripción

    other reason for withdrawal

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Please tick who took the decision
    Descripción

    Decision

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0679006
    UMLS CUI [1,2]
    C2348568
    Date of last contact
    Descripción

    Date of last contact

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject in good condition at date of last contact?
    Descripción

    Condition last contact

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Please specify your concerns about study subject's condition.
    Descripción

    Only fill in, if you answered previous question with 'no'.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    UMLS CUI [1,3]
    C1521902
    Subject's contact
    Descripción

    Subject's contact

    Alias
    UMLS CUI-1
    C0332158
    UMLS CUI-2
    C0681850
    Was the subject contacted between the previous scheduled contact/visit and this study conclusion ?
    Descripción

    Contact with study subject between visits

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C0681850
    Household exposure
    Descripción

    Household exposure

    Alias
    UMLS CUI-1
    C0020052
    UMLS CUI-2
    C0332157
    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 the previous contact and this study conclusion ?
    Descripción

    Household exposure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0020052
    Household Exposure
    Descripción

    Household Exposure

    Alias
    UMLS CUI-1
    C0020052
    UMLS CUI-2
    C0332157
    Household exposure No.
    Descripción

    Household exposure number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0020052
    UMLS CUI [1,3]
    C0449788
    Date of the exposure
    Descripción

    date of exposure

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0020052
    UMLS CUI [1,3]
    C0011008
    Type of exposure
    Descripción

    Type of exposure

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0332307
    Varicella or Zoster
    Descripción

    Varicella or Zoster

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-2
    C0740380
    Did the subject present any signs of varicella or zoster symptoms between the previous contact and this study conclusion ?
    Descripción

    Signs and symptoms varicella or zoster

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0740380
    How many episodes of symptoms of varicella or zoster?
    Descripción

    episodes of varicella or zoster

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C4086638
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [2,1]
    C4086638
    UMLS CUI [2,2]
    C0740380
    Investigator's signature
    Descripción

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Descripción

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's signature date
    Descripción

    Date of investigator's signature

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name
    Descripción

    Investigator name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
    Reason for non participation
    Descripción

    Reason for non participation

    Alias
    UMLS CUI-1
    C0558080
    UMLS CUI-2
    C0679823
    UMLS CUI-3
    C0392360
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Birth
    Descripción

    Date of Birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Reason for non participation
    Descripción

    Reason for non participation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Please specify criteria for non-eligibility.
    Descripción

    Subject not eligible? - please specify criteria that are not fullfilled:

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1555471
    UMLS CUI [1,2]
    C1521902
    Subject eligible but not willing to participate due to: Please specify:
    Descripción

    Only fill in, if you chose "Subject eligible but not willing to participate due to: Please specify:" before.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3846156
    UMLS CUI [1,2]
    C0392360
    Please specify serious adverse event which is the reason for the subject being not willing to participate
    Descripción

    Only fill in, if you chose "adverse events, or serious adverse event: please specify" before.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C1521902
    Please specify other reason for subject not willing to participate
    Descripción

    Only fill in if you chose "other" before.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2348568
    Date of death
    Descripción

    Only fill in, if you chose "Subject died on:" before.

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1148348
    Date of contact
    Descripción

    Date of contact

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705415
    UMLS CUI [1,3]
    C2348568
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    Similar models

    Phase A - Year 1 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Concomitant vaccination
    Item
    Has any vaccine other than the study vaccine(s) been administered between Visit 3 and Visit 4?
    boolean
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Concomitant vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Trade name of vaccine
    Item
    Trade / (Generic) Name
    text
    C0592503 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Administration route of vaccine
    Code List
    Route
    CL Item
    Intradermal  (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular  (IM)
    CL Item
    Intravenous  (IV)
    CL Item
    Intranasal  (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous  (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal  (TD)
    CL Item
    Unknown (UNK)
    Vaccine administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Medication
    Item
    Have any medications/treatments been administered between Visit 3 and Visit 4 according to protocol?
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade name of medication
    Item
    Trade / Generic name
    text
    C0592503 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medical indication for medication
    Item
    Medical indication
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Prophylactic medication
    Item
    Prophylactic
    boolean
    C0420172 (UMLS CUI [1])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route of administration
    Code List
    Route
    CL Item
    External (EXT)
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intraarticular (IR)
    CL Item
    Intrathecal (IT)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Rectal  (PR)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Topical (TO)
    CL Item
    Unknown (UNK)
    CL Item
    Vaginal (VA)
    Start Date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of Medication
    Item
    End date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuing
    Item
    Continuous medication
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    Occurrence of serious adverse event
    C1519255 (UMLS CUI-1)
    Serious adverse event
    Item
    Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
    boolean
    C1519255 (UMLS CUI [1])
    number of serious adverse events
    Item
    Specify total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Status of treatment blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    treatment blind broken
    Item
    Was the treatment blind broken between Visit 3 and Visit 4?
    boolean
    C2347038 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Date treatment blind broken
    Item
    Complete date treatment blind was broken.
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason for breaking treatment blind
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason treatment blind broken
    Code List
    Reason for breaking treatment blind
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other, specify (2)
    Item Group
    Elimination criteria
    C0680251 (UMLS CUI-1)
    Elimination criteria
    Item
    Did any elimination criteria become applicable between Visit 3 and Visit 4?
    boolean
    C0680251 (UMLS CUI [1])
    Specify elimination criteria
    Item
    Specify elimination criteria
    text
    C0680251 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    study subject participation status withdrawn
    Item
    Was the subject withdrawn from the study "Phase A year 1"?
    boolean
    C2348568 (UMLS CUI [1,1])
    C0422727 (UMLS CUI [1,2])
    Item
    Please tick the ONE most appropriate category for withdrawal.
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for withdrawal
    Code List
    Please tick the ONE most appropriate category for withdrawal.
    CL Item
    Serious adverse event (check Serious Adverse Event form) (SAE)
    CL Item
    Non-serious adverse event (check the Non-serious Adverse Event section) (AEX)
    CL Item
    Protocol violation (PTV)
    CL Item
    Consent withdrawal, not due to an adverse event. (CWS)
    CL Item
    Migrated / moved from the study area (MIG)
    CL Item
    Lost to follow-up (LFU)
    CL Item
    Other, please specify (e.g. non-serious AE for non-subset) (OTH)
    Number of serious adverse events
    Item
    Please specify SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of unsolicited adverse events
    Item
    Please specify unsolicited AE No
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    solicited adverse event code
    Item
    Please specify solicited AE code
    text
    C0877248 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    specify protocol violation
    Item
    Please specify protocol violation
    text
    C1709750 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    other reason for withdrawal
    Item
    Please specify other reason for study withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Please tick who took the decision
    text
    C0679006 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Decision
    Code List
    Please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents/Guardians (P)
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Condition last contact
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Specify study subjects condition
    Item
    Please specify your concerns about study subject's condition.
    text
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Subject's contact
    C0332158 (UMLS CUI-1)
    C0681850 (UMLS CUI-2)
    Contact with study subject between visits
    Item
    Was the subject contacted between the previous scheduled contact/visit and this study conclusion ?
    boolean
    C0332158 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Item Group
    Household exposure
    C0020052 (UMLS CUI-1)
    C0332157 (UMLS CUI-2)
    Household exposure
    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 the previous contact and this study conclusion ?
    boolean
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    Item Group
    Household Exposure
    C0020052 (UMLS CUI-1)
    C0332157 (UMLS CUI-2)
    Household exposure number
    Item
    Household exposure No.
    integer
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    date of exposure
    Item
    Date of the exposure
    date
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Type of exposure
    integer
    C0332157 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    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-2)
    Signs and symptoms varicella or zoster
    Item
    Did the subject present any signs of varicella or zoster symptoms between the previous contact and this study conclusion ?
    boolean
    C0037088 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0740380 (UMLS CUI [2,2])
    episodes of varicella or zoster
    Item
    How many episodes of symptoms of varicella or zoster?
    integer
    C4086638 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C4086638 (UMLS CUI [2,1])
    C0740380 (UMLS CUI [2,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Date of investigator's signature
    Item
    Investigator's signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Reason for non participation
    C0558080 (UMLS CUI-1)
    C0679823 (UMLS CUI-2)
    C0392360 (UMLS CUI-3)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Reason for non participation
    integer
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for non participation
    Code List
    Reason for non participation
    CL Item
    Subject not eligible? - please specify criteria that are not fulfilled: (1)
    CL Item
    Subject lost to follow-up or not reached (2)
    CL Item
    Subject eligible but not willing to participate due to: (3)
    CL Item
    Subject died on: (4)
    specify criteria non eligible
    Item
    Please specify criteria for non-eligibility.
    text
    C1555471 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    not willing to participate
    Item
    Subject eligible but not willing to participate due to: Please specify:
    text
    C3846156 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    specify serious adverse event
    Item
    Please specify serious adverse event which is the reason for the subject being not willing to participate
    text
    C2348568 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    specify other reason
    Item
    Please specify other reason for subject not willing to participate
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Date of death
    Item
    Date of death
    date
    C1148348 (UMLS CUI [1])
    Date of contact
    Item
    Date of contact
    date
    C0011008 (UMLS CUI [1,1])
    C1705415 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
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