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25260

Description

Phase A - Year 1 - Varicella /Zoster Case Form - 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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Versions (1)
  1. 8/29/17 8/29/17 -
Copyright Holder

glaxoSmithKline

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August 29, 2017

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Creative Commons BY-NC 3.0
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    Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    English

    Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms  
    Varicella or zoster case
    Description

    Varicella or zoster case

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-2
    C0740380
    Has any varicella or Zoster case occurred during the study period ?
    Description

    If yes, please complete below

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0740380
    Date telephone contact from parents/guardians to investigators
    Description

    Date telephone contact with investigator

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0302186
    UMLS CUI [1,2]
    C0011008
    Date of investigator visit
    Description

    Date of investigator visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512346
    UMLS CUI [1,2]
    C0011008
    Description
    Description

    Description

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0517733
    Macular Type
    Description

    Macular varicella

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0221201
    Papular Type
    Description

    Papular Varicella

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C1519353
    Mostly vesicular type
    Description

    vesicular varicella

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0221203
    Hemorrhagic type
    Description

    Hemorrhagic varicella

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0235498
    Intensity - Lesions and vesicles
    Description

    Intensity - Lesions and vesicles

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-2
    C0234687
    Date
    Description

    Date lesions are examined

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0011008
    Daily number of overall lesions
    Description

    Daily number of overall lesions

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0332173
    Daily number of overall vesicles
    Description

    Daily number of overall vesicles

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3814530
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0332173
    Subjective assessment of the illness by investigator
    Description

    Subjective assessment of the illness by investigator

    Alias
    UMLS CUI-1
    C0221423
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C0035173
    Please give the subjective assessment of the illness
    Description

    Subjective assessment of the illness by investigator

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0035173
    Photographs
    Description

    Photographs

    Alias
    UMLS CUI-1
    C0441468
    Have photographs been taken?
    Description

    photographs been taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0441468
    Dates of photographs
    Description

    Dates of photographs

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441468
    UMLS CUI [1,2]
    C0011008
    How many photographs have been taken?
    Description

    how many photographs

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0441468
    UMLS CUI [1,2]
    C0449788
    Weekdays location
    Description

    Weekdays location

    Alias
    UMLS CUI-1
    C0450429
    UMLS CUI-2
    C0680189
    Daycare
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008070
    Daycare: Frequency: number of days?
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008070
    UMLS CUI [1,2]
    C0439603
    Home
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case .

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0442519
    Home: Frequency: number of days?
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442519
    UMLS CUI [1,2]
    C0439603
    School
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036375
    School: Frequency: number of days?
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036375
    UMLS CUI [1,2]
    C0439603
    Childminder
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0730005
    Childminder: Frequency: number of days?
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0730005
    UMLS CUI [1,2]
    C0439603
    Number of children at childminder
    Description

    Number of children at childminder

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0730005
    UMLS CUI [1,2]
    C0008059
    UMLS CUI [1,3]
    C0449788
    Number of children with negative varicella history?
    Description

    at childminder

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0455469
    Number of children with negative varicella history unknown.
    Description

    Number of children with negative varicella history unknown

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0455469
    Other, specify:
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Other location
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C0205394
    Other location: Frequency: number of days?
    Description

    Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0439603
    Varicella or zoster index case
    Description

    Varicella or zoster index case

    Alias
    UMLS CUI-1
    C2597943
    UMLS CUI-2
    C0008049
    UMLS CUI-4
    C2597943
    UMLS CUI-5
    C0740380
    In the last 30 days (prior to onset of varicella or zoster case), was there a recognized exposure of the subject with an index case?
    Description

    Varicella or zoster index case

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [2,1]
    C2597943
    UMLS CUI [2,2]
    C0740380
    Type of contact
    Description

    Type of contact

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C0332307
    Frequency
    Description

    Frequency of contact

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0439603
    Date of contact
    Description

    Only answer if you choose "occasional contact"

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0008049
    Nature of contact
    Description

    Nature of contact

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392367
    UMLS CUI [1,2]
    C0332307
    Other: specify
    Description

    Specify other kind of contact

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392367
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Confirmation of index case
    Description

    Confirmation of index case

    Alias
    UMLS CUI-1
    C2597943
    UMLS CUI-2
    C0521091
    Local laboratory confirmed
    Description

    Local laboratory confirmed index case

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011911
    UMLS CUI [1,2]
    C2597943
    Diagnosis by a physician (whenever the physician's diagnosis of the index case is retrievable by the investigator)
    Description

    Diagnosis of index case by a physician

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [1,3]
    C0031831
    Part of a school / day care center / institutional outbreak for which confirmation can be obtained by the investigator from competent health authorities (e.g. school health service, school nurse or official surveillance network run by health authorities, as applicable)
    Description

    Index case confirmed at part of a school / day care center / institutional outbreak

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0036375
    UMLS CUI [2,1]
    C2597943
    UMLS CUI [2,2]
    C0008070
    UMLS CUI [3,1]
    C2597943
    UMLS CUI [3,2]
    C0012652
    UMLS CUI [3,3]
    C1272753
    Diagnosis by investigator
    Description

    Diagnosis of index case by investigator

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [1,3]
    C0035173
    By index-case parents
    Description

    Confirmed by index-case parents

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [1,3]
    C0750484
    Not confirmed
    Description

    Index case not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0521092
    Not confirmed
    Description

    Index case not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2597943
    UMLS CUI [1,2]
    C0521092
    Biological sample
    Description

    Biological sample

    Alias
    UMLS CUI-1
    C2347026
    UMLS CUI-2
    C0042338
    Have biological samples been taken?
    Description

    If yes, please complete the following table.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347026
    UMLS CUI [1,2]
    C0042338
    Biological sample
    Description

    Biological sample

    Alias
    UMLS CUI-1
    C2347026
    UMLS CUI-2
    C0042338
    Date
    Description

    Date sample has been taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347026
    UMLS CUI [1,2]
    C0011008
    Sequential Number
    Description

    Sequential Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C1705294
    Type
    Description

    Type of biological sample

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347026
    UMLS CUI [1,2]
    C0332307
    Last 4 digits of Label Code Bar
    Description

    Last 4 digits of Label Code Bar

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C3241971
    Rash
    Description

    Rash

    Alias
    UMLS CUI-1
    C0015230
    Date rash onset
    Description

    date when first lesion appears

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0574845
    Date rash end
    Description

    date of first day when no new lesions appear

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0806020
    Lesion - Intensity
    Description

    Lesion - Intensity

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C0234687
    Day
    Description

    Day 0-14 Day 0 should be date rash onset - Complete until date rash end

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0221198
    Daily number of overall Lesions
    Description

    Daily number of overall Lesions

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0332173
    Vesicles - Intensity
    Description

    Vesicles - Intensity

    Alias
    UMLS CUI-1
    C0333262
    UMLS CUI-2
    C0234687
    Day
    Description

    Day 0 should be date rash onset - Complete until date rash end

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0333262
    Daily number of overall Vesicles
    Description

    Daily number of overall Vesicles

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0333262
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0332173
    Temperature
    Description

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Route
    Description

    Please record all temperatures from date rash onset till date rash end Note: → If multiple measurements during a day, record the highest temperature → Only one route of temperature measurement should be used consistently

    Data type

    text

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

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Day
    Description

    Day 0-14 Please record all temperatures from date rash onset till date rash end Note: → If multiple measurements during a day, record the highest temperature → Only one route of temperature measurement should be used consistently

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0039476
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • degree Celsius
    Alias
    UMLS CUI [1]
    C0039476
    degree Celsius
    Not taken
    Description

    Temperature not taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039476
    Date varicella or zoster end
    Description

    Date varicella or zoster end

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-2
    C0806020
    UMLS CUI-4
    C0740380
    UMLS CUI-5
    C0806020
    Date varicella or zoster end
    Description

    date when subject resumes normal everyday activities.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C0740380
    UMLS CUI [2,2]
    C0806020
    Health economics
    Description

    Health economics

    Alias
    UMLS CUI-1
    C0013556
    UMLS CUI-2
    C0018684
    Did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness?
    Description

    work time lost due to care taking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0237107
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0585074
    How many hours?
    Description

    Only answer if you answered previous question with 'yes'. How many hours did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness ?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439227
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0030551
    Did the subject lose any days in the day care / childminder / school attendance or any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) during this illness ?
    Description

    time lost at day care / childminder / school attendance / extracurricular activity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2185951
    UMLS CUI [1,2]
    C0008070
    UMLS CUI [2,1]
    C2185951
    UMLS CUI [2,2]
    C0730005
    UMLS CUI [3,1]
    C2185951
    UMLS CUI [3,2]
    C0036375
    UMLS CUI [4,1]
    C2185951
    UMLS CUI [4,2]
    C0681383
    How many hours?
    Description

    Only answer if you answered previous question with 'yes'. How many hours did the subject lose in the day care / childminder / school attendance or at extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) during this illness?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439227
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0008059
    Did the parents / guardians request assistance from a nurse, a babysitter or any type of paid caregiver to look after the subject during this illness ?
    Description

    Assistance needed by nurse, babysitter or any type of paid caregiver

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3840284
    UMLS CUI [1,2]
    C0028661
    UMLS CUI [2,1]
    C3840284
    UMLS CUI [2,2]
    C0337606
    UMLS CUI [3,1]
    C3840284
    UMLS CUI [3,2]
    C0085537
    How many hours?
    Description

    How many hours did the parents / guardians request assistance from a nurse, a babysitter or any type of paid caregiver to look after the subject during this illness?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439227
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0085537
    If the subject were not participating in this trial, would the parents / guardians have contacted or visited a physician to seek medical advice for this illness ?
    Description

    Parents seeking medical advice for illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1386497
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [1,3]
    C2348568
    Pain
    Description

    Pain

    Alias
    UMLS CUI-1
    C0030193
    Did the subject present any back or abdominal pain during this varicella or zoster case ?
    Description

    back or abdominal pain varicella or zoster

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004604
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [1,3]
    C0740380
    UMLS CUI [2,1]
    C0000737
    UMLS CUI [2,2]
    C0008049
    UMLS CUI [2,3]
    C0740380
    Complications
    Description

    Complications

    Alias
    UMLS CUI-1
    C0009566
    Any complications as listed in the Protocol ?
    Description

    complications

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009566
    Serious adverse event (complete the Serious Adverse Event form)
    Description

    Only answer, if you answered previous question with 'yes'. Note: The diagnosis of varicella / zoster should be reported together with the complication as SAE

    Data type

    boolean

    Please specify SAE No:
    Description

    Number of serious adverse events

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Treatment
    Description

    Treatment

    Alias
    UMLS CUI-1
    C0087111
    Was any treatment given for the varicella or zoster case ?
    Description

    If you choose 'yes' please specify in Medication section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0740380
    Outcome
    Description

    Outcome

    Alias
    UMLS CUI-1
    C1547647
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547647
    Specify sequelae
    Description

    Only answer this question if you chose before'4 = Recovered with sequelae / resolved with sequelae'.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0243088
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    Similar models

    Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Varicella or zoster case
    C0008049 (UMLS CUI-1)
    C0740380 (UMLS CUI-2)
    Varicella or zoster case
    Item
    Has any varicella or Zoster case occurred during the study period ?
    boolean
    C0008049 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    Date telephone contact with investigator
    Item
    Date telephone contact from parents/guardians to investigators
    date
    C0302186 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of investigator visit
    Item
    Date of investigator visit
    date
    C1512346 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Description
    integer
    C0517733 (UMLS CUI [1])
    Description
    Code List
    Description
    CL Item
    Varicella (1)
    CL Item
    Zoster (2)
    Macular varicella
    Item
    Macular Type
    boolean
    C0008049 (UMLS CUI [1,1])
    C0221201 (UMLS CUI [1,2])
    Papular Varicella
    Item
    Papular Type
    boolean
    C0008049 (UMLS CUI [1,1])
    C1519353 (UMLS CUI [1,2])
    vesicular varicella
    Item
    Mostly vesicular type
    boolean
    C0008049 (UMLS CUI [1,1])
    C0221203 (UMLS CUI [1,2])
    Hemorrhagic varicella
    Item
    Hemorrhagic type
    boolean
    C0008049 (UMLS CUI [1,1])
    C0235498 (UMLS CUI [1,2])
    Item Group
    Intensity - Lesions and vesicles
    C0008049 (UMLS CUI-1)
    C0234687 (UMLS CUI-2)
    Date lesions are examined
    Item
    Date
    date
    C0221198 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Daily number of overall lesions
    integer
    C0221198 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0332173 (UMLS CUI [1,3])
    Daily number of overall lesions
    Code List
    Daily number of overall lesions
    CL Item
    1-50 (1)
    CL Item
    51-100 (2)
    CL Item
    101-500 (3)
    CL Item
    >500 (4)
    Item
    Daily number of overall vesicles
    integer
    C3814530 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0332173 (UMLS CUI [1,3])
    Daily number of overall vesicles
    Code List
    Daily number of overall vesicles
    CL Item
    None (1)
    CL Item
    1-10 (2)
    CL Item
    11-50 (3)
    CL Item
    >50 (4)
    Item Group
    Subjective assessment of the illness by investigator
    C0221423 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C0035173 (UMLS CUI-3)
    Item
    Please give the subjective assessment of the illness
    integer
    C0221423 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0035173 (UMLS CUI [1,3])
    Subjective assessment of the illness by investigator
    Code List
    Please give the subjective assessment of the illness
    CL Item
    Subject does not appear ill (1)
    CL Item
    Subject appears moderately ill (2)
    CL Item
    Subject appears severely ill (3)
    Item Group
    Photographs
    C0441468 (UMLS CUI-1)
    photographs been taken
    Item
    Have photographs been taken?
    boolean
    C0441468 (UMLS CUI [1])
    Dates of photographs
    Item
    Dates of photographs
    text
    C0441468 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    how many photographs
    Item
    How many photographs have been taken?
    integer
    C0441468 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Weekdays location
    C0450429 (UMLS CUI-1)
    C0680189 (UMLS CUI-2)
    Daycare
    Item
    Daycare
    boolean
    C0008070 (UMLS CUI [1])
    Frequency of time spend in daycare
    Item
    Daycare: Frequency: number of days?
    integer
    C0008070 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Home
    Item
    Home
    boolean
    C0442519 (UMLS CUI [1])
    Frequency of time spend at home
    Item
    Home: Frequency: number of days?
    integer
    C0442519 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    School
    Item
    School
    boolean
    C0036375 (UMLS CUI [1])
    Frequency of time spend at school
    Item
    School: Frequency: number of days?
    integer
    C0036375 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Childminder
    Item
    Childminder
    boolean
    C0730005 (UMLS CUI [1])
    Frequency of time spend at childminder
    Item
    Childminder: Frequency: number of days?
    integer
    C0730005 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Number of children at childminder
    Item
    Number of children at childminder
    integer
    C0730005 (UMLS CUI [1,1])
    C0008059 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Number of children with negative varicella history
    Item
    Number of children with negative varicella history?
    integer
    C0008059 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0455469 (UMLS CUI [1,3])
    Number of children with negative varicella history unknown
    Item
    Number of children with negative varicella history unknown.
    boolean
    C0008059 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0455469 (UMLS CUI [1,3])
    specify other location
    Item
    Other, specify:
    text
    C0450429 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Other location
    Item
    Other location
    boolean
    C0450429 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Frequency of time spend at other location
    Item
    Other location: Frequency: number of days?
    integer
    C0450429 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0439603 (UMLS CUI [1,3])
    Item Group
    Varicella or zoster index case
    C2597943 (UMLS CUI-1)
    C0008049 (UMLS CUI-2)
    C2597943 (UMLS CUI-4)
    C0740380 (UMLS CUI-5)
    Varicella or zoster index case
    Item
    In the last 30 days (prior to onset of varicella or zoster case), was there a recognized exposure of the subject with an index case?
    boolean
    C2597943 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C2597943 (UMLS CUI [2,1])
    C0740380 (UMLS CUI [2,2])
    Item
    Type of contact
    integer
    C0332158 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of contact
    Code List
    Type of contact
    CL Item
    Varicella (1)
    CL Item
    Zoster (2)
    Item
    Frequency
    integer
    C0008049 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0439603 (UMLS CUI [1,3])
    Frequency of contact
    Code List
    Frequency
    CL Item
    Occasional contact (1)
    CL Item
    Daily contact (2)
    Date of contact
    Item
    Date of contact
    date
    C0011008 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0008049 (UMLS CUI [1,3])
    Item
    Nature of contact
    integer
    C0392367 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Nature of contact
    Code List
    Nature of contact
    CL Item
    Household (1)
    CL Item
    Daycare center (2)
    CL Item
    Childminder (3)
    CL Item
    Playmate (4)
    CL Item
    School (in the same building) (5)
    CL Item
    School (in a different building) (6)
    CL Item
    Classroom (7)
    CL Item
    Other: specify (8)
    Specify other kind of contact
    Item
    Other: specify
    text
    C0392367 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Confirmation of index case
    C2597943 (UMLS CUI-1)
    C0521091 (UMLS CUI-2)
    Local laboratory confirmed index case
    Item
    Local laboratory confirmed
    boolean
    C0011911 (UMLS CUI [1,1])
    C2597943 (UMLS CUI [1,2])
    Diagnosis of index case by a physician
    Item
    Diagnosis by a physician (whenever the physician's diagnosis of the index case is retrievable by the investigator)
    boolean
    C2597943 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C0031831 (UMLS CUI [1,3])
    Index case confirmed at part of a school / day care center / institutional outbreak
    Item
    Part of a school / day care center / institutional outbreak for which confirmation can be obtained by the investigator from competent health authorities (e.g. school health service, school nurse or official surveillance network run by health authorities, as applicable)
    boolean
    C2597943 (UMLS CUI [1,1])
    C0036375 (UMLS CUI [1,2])
    C2597943 (UMLS CUI [2,1])
    C0008070 (UMLS CUI [2,2])
    C2597943 (UMLS CUI [3,1])
    C0012652 (UMLS CUI [3,2])
    C1272753 (UMLS CUI [3,3])
    Diagnosis of index case by investigator
    Item
    Diagnosis by investigator
    boolean
    C2597943 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C0035173 (UMLS CUI [1,3])
    Confirmed by index-case parents
    Item
    By index-case parents
    boolean
    C2597943 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0750484 (UMLS CUI [1,3])
    Index case not confirmed
    Item
    Not confirmed
    boolean
    C2597943 (UMLS CUI [1,1])
    C0521092 (UMLS CUI [1,2])
    Index case not confirmed
    Item
    Not confirmed
    boolean
    C2597943 (UMLS CUI [1,1])
    C0521092 (UMLS CUI [1,2])
    Item Group
    Biological sample
    C2347026 (UMLS CUI-1)
    C0042338 (UMLS CUI-2)
    Biological sample varicella
    Item
    Have biological samples been taken?
    boolean
    C2347026 (UMLS CUI [1,1])
    C0042338 (UMLS CUI [1,2])
    Item Group
    Biological sample
    C2347026 (UMLS CUI-1)
    C0042338 (UMLS CUI-2)
    Date sample has been taken
    Item
    Date
    date
    C2347026 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Sequential Number
    Item
    Sequential Number
    integer
    C0237753 (UMLS CUI [1,1])
    C1705294 (UMLS CUI [1,2])
    Item
    Type
    integer
    C2347026 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of biological sample
    Code List
    Type
    CL Item
    Vesicle (1)
    CL Item
    Papule (2)
    CL Item
    Crust (3)
    CL Item
    Throat (4)
    Last 4 digits of Label Code Bar
    Item
    Last 4 digits of Label Code Bar
    integer
    C0600091 (UMLS CUI [1,1])
    C3241971 (UMLS CUI [1,2])
    Item Group
    Rash
    C0015230 (UMLS CUI-1)
    Date rash onset
    Item
    Date rash onset
    date
    C0015230 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Date rash end
    Item
    Date rash end
    date
    C0015230 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item Group
    Lesion - Intensity
    C0221198 (UMLS CUI-1)
    C0234687 (UMLS CUI-2)
    Day
    Item
    Day
    integer
    C0439228 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    Item
    Daily number of overall Lesions
    integer
    C0221198 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0332173 (UMLS CUI [1,3])
    Daily number of overall Lesions
    Code List
    Daily number of overall Lesions
    CL Item
    1-50 (1)
    CL Item
    51-100 (2)
    CL Item
    101-500 (3)
    CL Item
    >500 (4)
    Item Group
    Vesicles - Intensity
    C0333262 (UMLS CUI-1)
    C0234687 (UMLS CUI-2)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0333262 (UMLS CUI [1,3])
    Item
    Daily number of overall Vesicles
    integer
    C0333262 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0332173 (UMLS CUI [1,3])
    undefined item
    Code List
    Daily number of overall Vesicles
    CL Item
    None (1)
    CL Item
    1-10 (2)
    CL Item
    11-50 (3)
    CL Item
    >50 (4)
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Item
    Route
    text
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Route body temperature
    Code List
    Route
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Day
    Item
    Day
    integer
    C0439228 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0039476 (UMLS CUI [1,3])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Temperature not taken
    Item
    Not taken
    boolean
    C0039476 (UMLS CUI [1])
    Item Group
    Date varicella or zoster end
    C0008049 (UMLS CUI-1)
    C0806020 (UMLS CUI-2)
    C0740380 (UMLS CUI-4)
    C0806020 (UMLS CUI-5)
    End Date Varicella or zoster
    Item
    Date varicella or zoster end
    date
    C0008049 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0740380 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item Group
    Health economics
    C0013556 (UMLS CUI-1)
    C0018684 (UMLS CUI-2)
    work time lost due to care taking
    Item
    Did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness?
    boolean
    C0237107 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0585074 (UMLS CUI [1,3])
    Amount of hours
    Item
    How many hours?
    integer
    C0439227 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0030551 (UMLS CUI [1,3])
    time lost at day care / childminder / school attendance / extracurricular activity
    Item
    Did the subject lose any days in the day care / childminder / school attendance or any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) during this illness ?
    boolean
    C2185951 (UMLS CUI [1,1])
    C0008070 (UMLS CUI [1,2])
    C2185951 (UMLS CUI [2,1])
    C0730005 (UMLS CUI [2,2])
    C2185951 (UMLS CUI [3,1])
    C0036375 (UMLS CUI [3,2])
    C2185951 (UMLS CUI [4,1])
    C0681383 (UMLS CUI [4,2])
    Amount of hours
    Item
    How many hours?
    integer
    C0439227 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0008059 (UMLS CUI [1,3])
    Assistance needed by nurse, babysitter or any type of paid caregiver
    Item
    Did the parents / guardians request assistance from a nurse, a babysitter or any type of paid caregiver to look after the subject during this illness ?
    boolean
    C3840284 (UMLS CUI [1,1])
    C0028661 (UMLS CUI [1,2])
    C3840284 (UMLS CUI [2,1])
    C0337606 (UMLS CUI [2,2])
    C3840284 (UMLS CUI [3,1])
    C0085537 (UMLS CUI [3,2])
    Amount of hours
    Item
    How many hours?
    integer
    C0439227 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0085537 (UMLS CUI [1,3])
    Parents seeking medical advice for illness
    Item
    If the subject were not participating in this trial, would the parents / guardians have contacted or visited a physician to seek medical advice for this illness ?
    boolean
    C1386497 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Item Group
    Pain
    C0030193 (UMLS CUI-1)
    back or abdominal pain varicella or zoster
    Item
    Did the subject present any back or abdominal pain during this varicella or zoster case ?
    boolean
    C0004604 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C0740380 (UMLS CUI [1,3])
    C0000737 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    C0740380 (UMLS CUI [2,3])
    Item Group
    Complications
    C0009566 (UMLS CUI-1)
    complications
    Item
    Any complications as listed in the Protocol ?
    boolean
    C0009566 (UMLS CUI [1])
    Serious adverse event
    Item
    Serious adverse event (complete the Serious Adverse Event form)
    boolean
    Number of serious adverse events
    Item
    Please specify SAE No:
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Treatment
    C0087111 (UMLS CUI-1)
    Treatment given for varicella or zoster
    Item
    Was any treatment given for the varicella or zoster case ?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0740380 (UMLS CUI [2,2])
    Item Group
    Outcome
    C1547647 (UMLS CUI-1)
    Item
    Outcome
    integer
    C1547647 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered / resolved (1)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
    Specify sequelae
    Item
    Specify sequelae
    text
    C0243088 (UMLS CUI [1])
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