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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1 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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  1. 27/08/17 27/08/17 -
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glaxoSmithKline

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27 agosto 2017

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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1

    Inglese

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1

    1 moduli  
    Solicited Symptoms
    Descrizione

    Solicited Symptoms

    Alias
    UMLS CUI-1
    C0683368
    UMLS CUI-2
    C1517001
    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 of pain at administration site Day 0

    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 of pain at administration site Day 1

    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 of pain at administration site Day 2

    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 of pain at administration site Day 3

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Temperature (day 0-day 14)
    Descrizione

    Temperature (day 0-day 14)

    Alias
    UMLS CUI-1
    C0039476
    Route of measurement
    Descrizione

    Please record axillary / rectal temperature daily from day 0 to day 14 after vaccination at bedtime. Only one route of temperature measurement should be used consistently. If temperature has been taken more than once a day, please report the highest value for the day.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0449444
    Temperature (day 0-day 14)
    Descrizione

    Temperature (day 0-day 14)

    Alias
    UMLS CUI-1
    C0039476
    Episode No.
    Descrizione

    Fever Episode Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0439228
    Temperature
    Descrizione

    Temperature

    Tipo di dati

    float

    Unità di misura
    • degree Celsius
    Alias
    UMLS CUI [1]
    C0039476
    degree Celsius
    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
    Temperature (day 15-day 42)
    Descrizione

    Temperature (day 15-day 42)

    Alias
    UMLS CUI-1
    C0039476
    Day
    Descrizione

    Day 15-42 Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0039476
    Fever
    Descrizione

    Fever

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Temperature
    Descrizione

    Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0039476
    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]
    C0332575
    Rash / exanthema (day 0-day 42)
    Descrizione

    Rash / exanthema (day 0-day 42)

    Alias
    UMLS CUI-1
    C0015230
    Episode No.
    Descrizione

    Please provide information on rash/exantem below. During the visit, physician will ask about more details - e.g. its description (size, shape, colour, lay-out, location, itching, soreness, etc.) Do not report here Varicella (Chickenpox) or Zoster (Shingles) here, but report in the Varicella (Chickenpox) or Zoster Case (Shingles) diary card section.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0449788
    Date started
    Descrizione

    Start Date of rash

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Descrizione

    End Date of rash

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0806020
    Intensity
    Descrizione

    Intensity of rash

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0518690
    Parotid / Salivary gland swelling events (day 0-day 42)
    Descrizione

    Parotid / Salivary gland swelling events (day 0-day 42)

    Alias
    UMLS CUI-1
    C0240925
    UMLS CUI-2
    C0240668
    Parotid swelling No.
    Descrizione

    Please provide information on parotid/salivary gland swelling below. During the visit, physician will ask about more details - e.g. its description (size, reddish skin, soreness, etc.)

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0449788
    Date started
    Descrizione

    Start date of parotid swelling

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Descrizione

    End date of parotid swelling

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0806020
    Intensity
    Descrizione

    Intensity of parotid swelling

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0518690
    Convulsion
    Descrizione

    Convulsion

    Alias
    UMLS CUI-1
    C4048158
    Convulsion No.
    Descrizione

    Please provide information on convulsions below. During the visit, physician will ask about more details - e.g. symptoms, description, etc.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C4048158
    UMLS CUI [1,2]
    C0449788
    Date and Time started
    Descrizione

    Start date and time of febrile convulsion

    Tipo di dati

    datetime

    Alias
    UMLS CUI [1,1]
    C4048158
    UMLS CUI [1,2]
    C2826806
    Date and Time stopped
    Descrizione

    End date and time of febrile convulsion

    Tipo di dati

    datetime

    Alias
    UMLS CUI [1,1]
    C4048158
    UMLS CUI [1,2]
    C2826793
    Fever
    Descrizione

    Fever

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Unsolicited symptoms (day 0 - day 42)
    Descrizione

    Unsolicited symptoms (day 0 - day 42)

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C4055646
    Description - please specify side(s) and site(s)
    Descrizione

    Description of unsolicited symptom

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C4055646
    UMLS CUI [1,3]
    C0678257
    Intensity
    Descrizione

    Intensity of unsolicited symptom

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0234687
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C4055646
    Start Date
    Descrizione

    Start date of unsolicited event

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C4055646
    UMLS CUI [1,3]
    C0808070
    End Date
    Descrizione

    End Date of unsolicited event

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C4055646
    UMLS CUI [1,3]
    C0806020
    Unsolicited symptom is continuing
    Descrizione

    Unsolicited symptom continuing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C4055646
    UMLS CUI [1,3]
    C0549178
    Medication (day 0 - day 42)
    Descrizione

    Medication (day 0 - day 42)

    Alias
    UMLS CUI-1
    C0013227
    Trade / Generic name
    Descrizione

    Please record all medication taken between Day 0 and Day 42 taken after Dose 1 according to the following criteria. All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending 43 days (Day 0 to Day 42) after each dose of study vaccine are to be recorded with name of the medication, reason for taking medication, total daily dose, start and end dates of treatment.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0013227
    Reason
    Descrizione

    Medical indication for medication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Total daily dose
    Descrizione

    Total daily dose

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Start Date
    Descrizione

    Start Date of medication

    Tipo di dati

    date

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

    End Date of Medication

    Tipo di dati

    date

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

    Medication continuing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Solicited Symptoms
    C0683368 (UMLS CUI-1)
    C1517001 (UMLS CUI-2)
    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])
    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 0
    Code List
    Intensity (of pain at administration site) Day 0
    CL Item
    Absent (0)
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries/protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    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 1
    Code List
    Intensity (of pain at administration site) Day 1
    CL Item
    Absent (0)
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries/protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    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 2
    Code List
    Intensity (of pain at administration site) Day 2
    CL Item
    Absent (0)
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries/protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    Item
    Intensity (of pain at administration site) Day 3
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 3
    Code List
    Intensity (of pain at administration site) Day 3
    CL Item
    Absent (0)
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries/protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    Item Group
    Temperature (day 0-day 14)
    C0039476 (UMLS CUI-1)
    Item
    Route of measurement
    text
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Fever
    Code List
    Route of measurement
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item Group
    Temperature (day 0-day 14)
    C0039476 (UMLS CUI-1)
    Item
    Episode No.
    integer
    C0015967 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Fever Episode Number
    Code List
    Episode No.
    CL Item
    Day 1 (01)
    CL Item
    Day 2 (02)
    CL Item
    Day 3 (03)
    CL Item
    Day 4 (04)
    CL Item
    Day 5 (05)
    CL Item
    Day 6 (06)
    CL Item
    Day 7 (07)
    CL Item
    Day 8 (08)
    CL Item
    Day 9 (09)
    CL Item
    Day 10 (10)
    CL Item
    Day 11 (11)
    CL Item
    Day 12 (12)
    CL Item
    Day 13 (13)
    CL Item
    Day 14 (14)
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Medically attended Visit
    Item
    Medically attended Visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    Item Group
    Temperature (day 15-day 42)
    C0039476 (UMLS CUI-1)
    Day
    Item
    Day
    integer
    C0439228 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0039476 (UMLS CUI [1,3])
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    boolean
    C0039476 (UMLS CUI [1])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [1,3])
    Item Group
    Rash / exanthema (day 0-day 42)
    C0015230 (UMLS CUI-1)
    rash number of episode
    Item
    Episode No.
    integer
    C0015230 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Start Date of rash
    Item
    Date started
    date
    C0015230 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of rash
    Item
    Date stopped
    date
    C0015230 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0015230 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of rash
    Code List
    Intensity
    CL Item
    1-50 lesions (1)
    CL Item
    51-100 lesions (2)
    CL Item
    101-500 lesions (3)
    CL Item
    >500 lesions (4)
    Item Group
    Parotid / Salivary gland swelling events (day 0-day 42)
    C0240925 (UMLS CUI-1)
    C0240668 (UMLS CUI-2)
    Parotid Swelling number
    Item
    Parotid swelling No.
    integer
    C0240668 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Start date of parotid swelling
    Item
    Date started
    date
    C0240668 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date of parotid swelling
    Item
    Date stopped
    date
    C0240668 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0240668 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of parotid swelling
    Code List
    Intensity
    CL Item
    Swelling without difficulties to move the jaw. (1)
    CL Item
    Swelling with difficulties to move the jaw. (2)
    CL Item
    Swelling and additional general symptoms. (3)
    Item Group
    Convulsion
    C4048158 (UMLS CUI-1)
    Convulsion number
    Item
    Convulsion No.
    integer
    C4048158 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Start date and time of febrile convulsion
    Item
    Date and Time started
    datetime
    C4048158 (UMLS CUI [1,1])
    C2826806 (UMLS CUI [1,2])
    End date and time of febrile convulsion
    Item
    Date and Time stopped
    datetime
    C4048158 (UMLS CUI [1,1])
    C2826793 (UMLS CUI [1,2])
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Item Group
    Unsolicited symptoms (day 0 - day 42)
    C1457887 (UMLS CUI-1)
    C4055646 (UMLS CUI-2)
    Description of unsolicited symptom
    Item
    Description - please specify side(s) and site(s)
    text
    C1457887 (UMLS CUI [1,1])
    C4055646 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Item
    Intensity
    integer
    C0234687 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C4055646 (UMLS CUI [1,3])
    Intensity of unsolicited symptom
    Code List
    Intensity
    CL Item
    Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
    CL Item
    Moderate: An adverse event which is sufficiently discomforting to interfere with normal every day activities. (2)
    CL Item
    Moderate: An adverse event which is sufficiently discomforting to interfere with normal every day activities. (2)
    CL Item
    Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice) (3)
    Start date of unsolicited event
    Item
    Start Date
    date
    C1457887 (UMLS CUI [1,1])
    C4055646 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    End Date of unsolicited event
    Item
    End Date
    date
    C1457887 (UMLS CUI [1,1])
    C4055646 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Unsolicited symptom continuing
    Item
    Unsolicited symptom is continuing
    boolean
    C1457887 (UMLS CUI [1,1])
    C4055646 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    Item Group
    Medication (day 0 - day 42)
    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
    Reason
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    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])
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