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ID

28998

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

    English

    Diary Card, local and general symptoms

    2 forms  
    Redness day and size
    Description

    Redness day and size

    Alias
    UMLS CUI-1
    C0332575
    UMLS CUI-2
    C0456389
    UMLS CUI-3
    C2700396
    Redness day
    Description

    Redness day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0332575
    Redness size
    Description

    Redness size

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Redness
    Description

    Redness

    Alias
    UMLS CUI-1
    C0332575
    UMLS CUI-2
    C2700396
    Ongoing after Day 3?
    Description

    Ongoing redness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0549178
    UMLS CUI [1,3]
    C2700396
    Date of last day of symptoms of redness:
    Description

    If you answered the previous question with yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0332575
    UMLS CUI [1,3]
    C2700396
    Medically attended visit concerning redness
    Description

    Medically attended visit concerning redness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0332575
    Swelling day and size
    Description

    Swelling day and size

    Alias
    UMLS CUI-1
    C0038999
    UMLS CUI-2
    C0456389
    UMLS CUI-3
    C2700396
    Swelling day
    Description

    Swelling day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0038999
    Swelling size
    Description

    Swelling size

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Swelling
    Description

    Swelling

    Alias
    UMLS CUI-1
    C0038999
    Swelling ongoing after day 3?
    Description

    Ongoing Swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0549178
    UMLS CUI [1,3]
    C2700396
    Date of last day of symptoms of swelling:
    Description

    If you answered the previous question with yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C2700396
    Medically attended visit concerning swelling
    Description

    Medically attended visit concerning swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0038999
    Pain day and intensity
    Description

    Pain day and intensity

    Alias
    UMLS CUI-1
    C0030193
    UMLS CUI-2
    C0522510
    UMLS CUI-3
    C2700396
    Pain day
    Description

    Pain day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0030193
    Pain intensity
    Description

    Pain intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain
    Description

    Pain

    Alias
    UMLS CUI-1
    C0030193
    Pain ongoing after day 3?
    Description

    Ongoing pain

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0549178
    UMLS CUI [1,3]
    C2700396
    Date of last day of symptoms of pain:
    Description

    If you answered the previous question with yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C2700396
    Medically attended visit concerning pain
    Description

    Medically attended visit concerning pain

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0030193
    Other local symptoms
    Description

    Other local symptoms

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    Description - please specify side(s) and site(s)
    Description

    Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0205276
    Intensity
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Start date
    Description

    Start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Check box if continuing
    Description

    Continuing symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    Temperature day and °C
    Description

    Temperature day and °C

    Alias
    UMLS CUI-1
    C0518690
    UMLS CUI-2
    C0039476
    Temperature day
    Description

    Temperature day

    Data type

    integer

    Temperature °C axillary, evening
    Description

    Temperature °C axillary

    Data type

    integer

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C1531924
    °C
    Temperature
    Description

    Temperature

    Alias
    UMLS CUI-1
    C0005903
    Fever ongoing after day 3?
    Description

    Ongoing fever

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms of fever
    Description

    If you answered the previous question with yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0015967
    Medically attended visit concerning fever
    Description

    Medically attended visit concerning fever

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
    Irritability/Fussiness day and intensity
    Description

    Irritability/Fussiness day and intensity

    Alias
    UMLS CUI-1
    C0022107
    UMLS CUI-2
    C0522510
    Irritability/Fussiness day
    Description

    Irritability/Fussiness day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0439228
    Irritability/Fussiness intensity
    Description

    Irritability/Fussiness intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0522510
    Irritability / Fussiness
    Description

    Irritability / Fussiness

    Alias
    UMLS CUI-1
    C0022107
    Irritability / Fussiness ongoing after day 3?
    Description

    Ongoing Irritability / Fussiness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0549178
    Date of last Irritability / Fussiness
    Description

    Date of last Irritability / Fussiness

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0011008
    Medically attended visit concerning Irritability / Fussiness
    Description

    Medically attended visit concerning Irritability / Fussiness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0022107
    Drowsiness day and intensity
    Description

    Drowsiness day and intensity

    Alias
    UMLS CUI-1
    C0013144
    UMLS CUI-2
    C0522510
    Drowsiness day
    Description

    Drowsiness day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0439228
    Drowsiness intensity
    Description

    Drowsiness intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Drowsiness
    Description

    Drowsiness

    Alias
    UMLS CUI-1
    C0013144
    Ongoing after Day 3?
    Description

    Ongoing drowsiness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0549178
    Date of last Day of Symptoms
    Description

    Date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0011008
    Medically attended visit concerning drowsiness
    Description

    Medically attended visit concerning drowsiness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0013144
    Loss of appetite day and intensity
    Description

    Loss of appetite day and intensity

    Alias
    UMLS CUI-1
    C1971624
    UMLS CUI-2
    C0522510
    Loss of appetite day
    Description

    Loss of appetite day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C1971624
    Loss of appetite intensity
    Description

    Loss of appetite intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite
    Description

    Loss of appetite

    Alias
    UMLS CUI-1
    C1971624
    Ongoing after Day 3?
    Description

    Ongoing loss of appetite

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0549178
    Date of last Day of Symptoms
    Description

    Date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0011008
    Medically attended visit concerning loss of appetite
    Description

    Medically attended visit concerning loss of appetite

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1971624
    Other general symptoms
    Description

    Other general symptoms

    Alias
    UMLS CUI-1
    C0029625
    Description - please give details below
    Description

    Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0029625
    Intensity
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0159028
    Start date
    Description

    Start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Check box if continuing
    Description

    Continuing general symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0029625
    UMLS CUI [1,2]
    C0549178
    Medically attended visit?
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0029625
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade/Generic name
    Description

    Please fill in below if any medication has been taken since the vaccination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2360065
    Reason
    Description

    Reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C0392360
    Total daily dose
    Description

    Total daily dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348070
    Start date
    Description

    Start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Check box if continuing
    Description

    Continuing medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    General information Dairy card
    Description

    General information Dairy card

    Alias
    UMLS CUI-1
    C1508263
    Please do not forget to bring back the diary card on:
    Description

    Return of Diary card

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C1548100
    In case of hospitalization please inform:
    Description

    Hospitalisation information

    Data type

    text

    Alias
    UMLS CUI [1]
    C0019993
    In case of hospitalization please inform:
    Description

    Hospitalisation information

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019993
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    Similar models

    Diary Card, local and general symptoms

    2 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Redness day and size
    C0332575 (UMLS CUI-1)
    C0456389 (UMLS CUI-2)
    C2700396 (UMLS CUI-3)
    Item
    Redness day
    integer
    C0439228 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    Redness day
    Code List
    Redness day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3  (4)
    Redness size
    Item
    Redness size
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Item Group
    Redness
    C0332575 (UMLS CUI-1)
    C2700396 (UMLS CUI-2)
    Ongoing redness
    Item
    Ongoing after Day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Ongoing redness
    Item
    Date of last day of symptoms of redness:
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit concerning redness
    Item
    Medically attended visit concerning redness
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [1,3])
    Item Group
    Swelling day and size
    C0038999 (UMLS CUI-1)
    C0456389 (UMLS CUI-2)
    C2700396 (UMLS CUI-3)
    Item
    Swelling day
    integer
    C0439228 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    Swelling day
    Code List
    Swelling day
    CL Item
    Day 0  (1)
    CL Item
    Day 1  (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3 (4)
    Swelling size
    Item
    Swelling size
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Item Group
    Swelling
    C0038999 (UMLS CUI-1)
    Ongoing Swelling
    Item
    Swelling ongoing after day 3?
    boolean
    C0038999 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Ongoing swelling
    Item
    Date of last day of symptoms of swelling:
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit concerning swelling
    Item
    Medically attended visit concerning swelling
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [1,3])
    Item Group
    Pain day and intensity
    C0030193 (UMLS CUI-1)
    C0522510 (UMLS CUI-2)
    C2700396 (UMLS CUI-3)
    Item
    Pain day
    integer
    C0439228 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    Pain day
    Code List
    Pain day
    CL Item
    Day 0  (1)
    CL Item
    Day 1  (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3 (4)
    Item
    Pain intensity
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain intensity
    Code List
    Pain intensity
    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
    Pain
    C0030193 (UMLS CUI-1)
    Ongoing pain
    Item
    Pain ongoing after day 3?
    boolean
    C0030193 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Ongoing pain
    Item
    Date of last day of symptoms of pain:
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit concerning pain
    Item
    Medically attended visit concerning pain
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    Item Group
    Other local symptoms
    C0205394 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Description
    Item
    Description - please specify side(s) and site(s)
    text
    C0678257 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1])
    Intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Continuing symptoms
    Item
    Check box if continuing
    boolean
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    Temperature day and °C
    C0518690 (UMLS CUI-1)
    C0039476 (UMLS CUI-2)
    Item
    Temperature day
    integer
    Temperature day
    Code List
    Temperature day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Temperature °C axillary
    Item
    Temperature °C axillary, evening
    integer
    C1531924 (UMLS CUI [1])
    Item Group
    Temperature
    C0005903 (UMLS CUI-1)
    Ongoing fever
    Item
    Fever ongoing after day 3?
    boolean
    C0015967 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Last date of fever
    Item
    Date of last day of symptoms of fever
    date
    C0011008 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Medically attended visit concerning fever
    Item
    Medically attended visit concerning fever
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    Item Group
    Irritability/Fussiness day and intensity
    C0022107 (UMLS CUI-1)
    C0522510 (UMLS CUI-2)
    Item
    Irritability/Fussiness day
    integer
    C0022107 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Irritability/Fussiness day
    Code List
    Irritability/Fussiness day
    CL Item
    Day 0  (1)
    CL Item
    Day 1  (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3 (4)
    Item
    Irritability/Fussiness intensity
    integer
    C0022107 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Irritability/Fussiness intensity
    Code List
    Irritability/Fussiness intensity
    CL Item
    Behavior as usual (0)
    CL Item
    Crying more than usual / no effect on normal activity (1)
    CL Item
    Crying more than usual / interferes with normal activity (2)
    CL Item
    Crying that cannot be comforted / prevents normal activity (3)
    Item Group
    Irritability / Fussiness
    C0022107 (UMLS CUI-1)
    Ongoing Irritability / Fussiness
    Item
    Irritability / Fussiness ongoing after day 3?
    boolean
    C0022107 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last Irritability / Fussiness
    Item
    Date of last Irritability / Fussiness
    date
    C0022107 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Medically attended visit concerning Irritability / Fussiness
    Item
    Medically attended visit concerning Irritability / Fussiness
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0022107 (UMLS CUI [1,3])
    Item Group
    Drowsiness day and intensity
    C0013144 (UMLS CUI-1)
    C0522510 (UMLS CUI-2)
    Item
    Drowsiness day
    integer
    C0013144 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Drowsiness day
    Code List
    Drowsiness day
    CL Item
    Day 0  (1)
    CL Item
    Day 1  (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3 (4)
    Item
    Drowsiness intensity
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Drowsiness intensity
    Code List
    Drowsiness intensity
    CL Item
    Behavior as usual (1)
    (Comment:en)
    CL Item
    Drowsiness easily tolerated (2)
    (Comment:en)
    CL Item
    Drowsiness that interferes with normal activity (3)
    (Comment:en)
    CL Item
    Drowsiness that prevents normal activity (4)
    (Comment:en)
    Item Group
    Drowsiness
    C0013144 (UMLS CUI-1)
    Ongoing drowsiness
    Item
    Ongoing after Day 3?
    boolean
    C0013144 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last Day of Symptoms
    Item
    Date of last Day of Symptoms
    date
    C0013144 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Medically attended visit concerning drowsiness
    Item
    Medically attended visit concerning drowsiness
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [1,3])
    Item Group
    Loss of appetite day and intensity
    C1971624 (UMLS CUI-1)
    C0522510 (UMLS CUI-2)
    Item
    Loss of appetite day
    integer
    C0439228 (UMLS CUI [1,1])
    C1971624 (UMLS CUI [1,2])
    Loss of appetite day
    Code List
    Loss of appetite day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Loss of appetite intensity
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite intensity
    Code List
    Loss of appetite intensity
    CL Item
    Appetite as usual (0)
    CL Item
    Eating less than usual / no effect on normal activity (1)
    CL Item
    Eating less than usual / interferes with normalactivity (2)
    CL Item
    Not eating at all (3)
    Item Group
    Loss of appetite
    C1971624 (UMLS CUI-1)
    Ongoing loss of appetite
    Item
    Ongoing after Day 3?
    boolean
    C1971624 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last Day of Symptoms
    Item
    Date of last Day of Symptoms
    date
    C1971624 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Medically attended visit concerning loss of appetite
    Item
    Medically attended visit concerning loss of appetite
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [1,3])
    Item Group
    Other general symptoms
    C0029625 (UMLS CUI-1)
    Description
    Item
    Description - please give details below
    text
    C0678257 (UMLS CUI [1,1])
    C0029625 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1,1])
    C0159028 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Continuing general symptoms
    Item
    Check box if continuing
    boolean
    C0029625 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0029625 (UMLS CUI [1,3])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade/Generic name
    Item
    Trade/Generic name
    text
    C0013227 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    Total daily dose
    Item
    Total daily dose
    integer
    C2348070 (UMLS CUI [1])
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Continuing medication
    Item
    Check box if continuing
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    General information Dairy card
    C1508263 (UMLS CUI-1)
    Return of Diary card
    Item
    Please do not forget to bring back the diary card on:
    date
    C0011008 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C1548100 (UMLS CUI [1,4])
    Hospitalisation information
    Item
    In case of hospitalization please inform:
    text
    C0019993 (UMLS CUI [1])
    Hospitalisation information
    Item
    In case of hospitalization please inform:
    integer
    C0019993 (UMLS CUI [1])
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