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ID

34653

Description

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (3)
  1. 1/15/19 1/15/19 -
  2. 1/18/19 1/18/19 -
  3. 1/22/19 1/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

    English

    Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

    1 forms  
    General medical history/ Physical examination
    Description

    General medical history/ Physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Are you aware of any pre- existing conditions or signs and/ or symptoms present in the subject prior to the start of the study?
    Description

    If yes, tick appropriate box(es) and give diagnosis.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521987
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C2347662
    UMLS CUI [2,3]
    C0332152
    UMLS CUI [2,4]
    C2347804
    Diagnosis
    Description

    Diagnosis

    Alias
    UMLS CUI-1
    C0011900
    Medical condition
    Description

    Medical condition

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0012634
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Medical Condition Status
    Description

    Medical Condition Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Baseline Measurement of mid left thigh circumference
    Description

    Baseline Measurement of mid left thigh circumference

    Alias
    UMLS CUI-1
    C0230426
    UMLS CUI-2
    C0444598
    UMLS CUI-3
    C0424682
    Circumference of mid left thigh
    Description

    Circumference of mid left thigh

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0230426
    UMLS CUI [1,2]
    C0444598
    UMLS CUI [1,3]
    C0424682
    mm
    Vaccine administration
    Description

    Vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    Date of vaccination
    Description

    Fill in only if different from visit date.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0042196
    Pre- Vaccination temperature
    Description

    Route: Axillary

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0332152
    °C
    Vaccine administration
    Description

    Only one box must be ticked by vaccine.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2368628
    Why not administered?
    Description

    Please tick the ONE most appropriate category for non administration.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Replacement vial
    Description

    Replacement vial

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    Wrong vial number
    Description

    Wrong vial number

    Data type

    text

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

    Protocol: Left anterolateral thigh i.m.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    If study vaccine has not been administered according to the Protocol, check all that apply.
    Description

    Protocol: Left anterolateral thigh i.m.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [1,3]
    C0205394
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    If other reason for vaccine not administered, please specify.
    Description

    If other reason for vaccine not administered, please specify.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    UMLS CUI [1,4]
    C2348235
    If vaccine not administered, please tick who took the decision
    Description

    If vaccine not administered, please tick who took the decision

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [1,3]
    C0679006
    Unsolicited Adverse events
    Description

    Unsolicited Adverse events

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?
    Description

    Has the subject experienced any serious or non- serious unsolicited adverse events

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0687676
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C2368628
    UMLS CUI [2,3]
    C0687676
    Solicited Adverse Events - Local Symptoms
    Description

    Solicited Adverse Events - Local Symptoms

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
    Description

    Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0042210
    Redness
    Description

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0332575
    If redness, enter size at Day 0
    Description

    Size of redness Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0011008
    mm
    If redness, enter size at Day 1
    Description

    Size of redness Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0011008
    mm
    If redness, enter size at Day 2
    Description

    Size of redness Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0011008
    mm
    If redness, enter size at Day 3
    Description

    Size of redness Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0011008
    mm
    Redness ongoing after day 3?
    Description

    Redness ongoing after day 3?

    Data type

    boolean

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

    Date of last day of redness

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0806020
    Redness - medically attended visit?
    Description

    Redness - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0332575
    Redness - specify medically attended visit
    Description

    Redness - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0332575
    UMLS CUI [1,4]
    C2348235
    Swelling
    Description

    In case of large swelling reaction at the administration site, please fill in ALSO the Large Swelling Reaction report.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038999
    If swelling, enter size at Day 0
    Description

    Size of swelling Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C0011008
    mm
    If swelling, enter size at Day 1
    Description

    Size of swelling Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C0011008
    mm
    If swelling, enter size at Day 2
    Description

    Size of swelling Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C0011008
    mm
    If swelling, enter size at Day 3
    Description

    Size of swelling Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C0011008
    mm
    Swelling ongoing after day 3?
    Description

    Swelling ongoing after day 3?

    Data type

    boolean

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

    Date of last day of swelling

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0806020
    Swelling - medically attended visit?
    Description

    Swelling - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0038999
    Swelling - specify medically attended visit
    Description

    Sewlling - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0038999
    UMLS CUI [1,4]
    C2348235
    Pain
    Description

    Pain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030193
    If pain, enter Intensity at Day 0
    Description

    Intensity of pain Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1320357
    UMLS CUI [1,2]
    C0011008
    If pain, enter Intensity at Day 1
    Description

    Intensity of pain Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1320357
    UMLS CUI [1,2]
    C0011008
    If pain, enter Intensity at Day 2
    Description

    Intensity of pain Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1320357
    UMLS CUI [1,2]
    C0011008
    If pain, enter Intensity at Day 3
    Description

    Intensity of pain Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1320357
    UMLS CUI [1,2]
    C0011008
    Pain ongoing after day 3?
    Description

    Pain ongoing after day 3?

    Data type

    boolean

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

    Date of last day of pain

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0806020
    Pain - medically attended visit?
    Description

    Pain - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0030193
    Pain - specify medically attended visit
    Description

    Pain - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0030193
    UMLS CUI [1,4]
    C2348235
    Soliced Adverse Events - General Symptoms
    Description

    Soliced Adverse Events - General Symptoms

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0159028
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    Description

    Signs/symptoms during the solicited period

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0042210
    General Symptoms
    Description

    General Symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0159028
    Fever - Body temperature Day 0
    Description

    Fever - Body temperature Day 0

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0039476
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    °C
    Fever - Body temperature Day 0 not taken
    Description

    Fever - Body temperature Day 0 not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0437722
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    Fever - Body temperature Day 1
    Description

    Fever - Body temperature Day 1

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0039476
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    °C
    Fever - Body temperature Day 1 not taken
    Description

    Fever - Body temperature Day 1 not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0437722
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    Fever - Body temperature Day 2
    Description

    Fever - Body temperature Day 2

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0039476
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    °C
    Fever - Body temperature Day 2 not taken
    Description

    Fever - Body temperature Day 2 not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0437722
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    Fever - Body temperature Day 3
    Description

    Fever - Body temperature Day 3

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1,1]
    C0039476
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    °C
    Fever - Body temperature Day 3 not taken
    Description

    Fever - Body temperature Day 3 not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0437722
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0011008
    Is fever ongoing after day 3?
    Description

    Is fever ongoing after day 3?

    Data type

    boolean

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

    Date of last day of fever.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0806020
    Fever - Causality?
    Description

    Fever - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0015127
    Fever - medically attended visit?
    Description

    Fever - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
    Fever - specify medically attended visit.
    Description

    Fever - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
    UMLS CUI [1,4]
    C2348235
    Irritability/ Fussiness - Intensity Day 0
    Description

    Irritability/ Fussiness - Intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Irritability/ Fussiness - Intensity Day 1
    Description

    Irritability/ Fussiness - Intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Irritability/ Fussiness - Intensity Day 2
    Description

    Irritability/ Fussiness - Intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Irritability/ Fussiness - Intensity Day 3
    Description

    Irritability/ Fussiness - Intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Is irritability/ fussiness ongoing after day 3?
    Description

    Is irritability/ fussiness ongoing after day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0549178
    Date of last day of irritability/ fussiness.
    Description

    Date of last day of irritability/ fussiness.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0806020
    Irritability/ Fussiness- Causality?
    Description

    Irritability/ Fussiness- Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0015127
    Irritability/Fussiness - medically attended visit?
    Description

    Irritability/ Fussiness- medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0022107
    Irritability/ Fussiness- specify medically attended visit.
    Description

    Irritability/ Fussiness - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0022107
    UMLS CUI [1,4]
    C2348235
    Drowsiness - Intensity Day 0
    Description

    Drowsiness - Intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Drowsiness - Intensity Day 1
    Description

    Drowsiness - Intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Drowsiness - Intensity Day 2
    Description

    Drowsiness - Intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Drowsiness - Intensity Day 3
    Description

    Drowsiness - Intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Is drowsiness ongoing after day 3?
    Description

    Is drowsiness ongoing after day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0549178
    Date of last day of drowsiness.
    Description

    Date of last day of drowsiness.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0806020
    Drowsiness - Causality?
    Description

    Drowsiness - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0015127
    Drowsiness - medically attended visit?
    Description

    Drowsiness - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0013144
    Drowsiness - specify medically attended visit.
    Description

    Drowsiness - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0013144
    UMLS CUI [1,4]
    C2348235
    Loss of appetite - Intensity Day 0
    Description

    Loss of appetite - Intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Loss of appetite - Intensity Day 1
    Description

    Loss of appetite - Intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Loss of appetite - Intensity Day 2
    Description

    Loss of appetite - Intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Loss of appetite - Intensity Day 3
    Description

    Loss of appetite - Intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0011008
    Is loss of appetite ongoing after day 3?
    Description

    Is loss of appetite ongoing after day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0549178
    Date of last day of loss of appetite.
    Description

    If loss of appetite is ongoing after day 3, record date of last day of symptoms.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0806020
    Loss of appetite - Causality?
    Description

    Loss of appetite - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0015127
    Loss of appetite - medically attended visit?
    Description

    Loss of appetite - medically attended visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1971624
    Loss of appetite - specify medically attended visit.
    Description

    Loss of appetite - specify medically attended visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1971624
    UMLS CUI [1,4]
    C2348235
    In case of intensity 3: Was the crying continuous (i.e. episodic, not interrupted within the time period of 3 hours by e.g. naps)?
    Description

    In case of intensity 3: Was the crying continuous

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518690
    UMLS CUI [2]
    C2721683
    In case of intensity 3: was the crying unaltered >=3 hours?
    Description

    In case of intensity 3: was the crying unaltered >=3 hours?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0438697
    UMLS CUI [1,3]
    C0449238
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    Similar models

    Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    General medical history/ Physical examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Pre- existing conditions or signs and/ or symptoms present in the subject
    Item
    Are you aware of any pre- existing conditions or signs and/ or symptoms present in the subject prior to the start of the study?
    boolean
    C0521987 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    C0037088 (UMLS CUI [2,1])
    C2347662 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [2,3])
    C2347804 (UMLS CUI [2,4])
    Item Group
    Diagnosis
    C0011900 (UMLS CUI-1)
    Item
    Medical condition
    integer
    C0012634 (UMLS CUI [1])
    Location/ System
    Code List
    Medical condition
    CL Item
    Cutaneous (10)
    CL Item
    Eyes (5)
    CL Item
    Ears- Nose- Throat (6)
    CL Item
    Cardiovascular (2)
    CL Item
    Respiratory (3)
    CL Item
    GAstrointestinal (1)
    CL Item
    Muskuloskeletal (7)
    CL Item
    Neurological (8)
    CL Item
    Genitourinary (12)
    CL Item
    Haematology (11)
    CL Item
    Allergies (4)
    CL Item
    Endocrine (9)
    CL Item
    Persistent crying (crying continuous [i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps] and unaltered >= 3 hours.) (13)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Medical Condition Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Medical Condition Status
    Code List
    Medical Condition Status
    CL Item
    Past (1)
    CL Item
    Current (2)
    Item Group
    Baseline Measurement of mid left thigh circumference
    C0230426 (UMLS CUI-1)
    C0444598 (UMLS CUI-2)
    C0424682 (UMLS CUI-3)
    Circumference of mid left thigh
    Item
    Circumference of mid left thigh
    integer
    C0230426 (UMLS CUI [1,1])
    C0444598 (UMLS CUI [1,2])
    C0424682 (UMLS CUI [1,3])
    Item Group
    Vaccine administration
    C2368628 (UMLS CUI-1)
    Date of vaccination
    Item
    Date of vaccination
    date
    C0011008 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Pre- Vaccination temperature
    Item
    Pre- Vaccination temperature
    float
    C0005903 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Item
    Vaccine administration
    text
    C2368628 (UMLS CUI [1])
    Vaccine administration
    Code List
    Vaccine administration
    CL Item
    DTPw- HBV/Hib Vaccine (S)
    CL Item
    DTPw- HBV/Hib Vaccine (S)
    CL Item
    Replacement vial (R)
    CL Item
    Wrong vial number (W)
    CL Item
    Not administered (N)
    Item
    Why not administered?
    text
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Why not administered?
    Code List
    Why not administered?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non- serious adverse event (complete the Non- serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation,...) (OTH)
    Replacement vial
    Item
    Replacement vial
    text
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    Wrong vial number
    Item
    Wrong vial number
    text
    C0184301 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C3827420 (UMLS CUI [1,3])
    Has the study vaccine been administered according to the Protocol
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Item
    If study vaccine has not been administered according to the Protocol, check all that apply.
    text
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    If study vaccine has not been administered according to the Protocol, check all that apply.
    Code List
    If study vaccine has not been administered according to the Protocol, check all that apply.
    CL Item
    Left side (L)
    CL Item
    Right side (R)
    CL Item
    Deltoid (1)
    CL Item
    Thigh (3)
    CL Item
    Buttock (6)
    CL Item
    I.M. (IM)
    CL Item
    S.C. (SC)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    If other reason for vaccine not administered, please specify.
    Item
    If other reason for vaccine not administered, please specify.
    text
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    If vaccine not administered, please tick who took the decision
    text
    C2368628 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    If vaccine not administered, please tick who took the decision
    Code List
    If vaccine not administered, please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents/ Guardians (P)
    Item Group
    Unsolicited Adverse events
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?
    text
    C1518404 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0687676 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    C0687676 (UMLS CUI [2,3])
    Has the subject experienced any serious or non- serious unsolicited adverse events
    Code List
    Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, fill in the Non- Serious Adverse Event pages or Serious Adverse Event form. (Y)
    Item Group
    Solicited Adverse Events - Local Symptoms
    C0877248 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
    text
    C0037088 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0042210 (UMLS CUI [1,4])
    Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
    Code List
    Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
    CL Item
    Information not available (U)
    CL Item
    No vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/ Yes for each symptom. If yes is ticked, please complete all items. (Y)
    Redness
    Item
    Redness
    boolean
    C0332575 (UMLS CUI [1])
    Size of redness Day 0
    Item
    If redness, enter size at Day 0
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of redness Day 1
    Item
    If redness, enter size at Day 1
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of redness Day 2
    Item
    If redness, enter size at Day 2
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of redness Day 3
    Item
    If redness, enter size at Day 3
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Redness ongoing after day 3?
    Item
    Redness ongoing after day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of redness
    Item
    Date of last day of redness
    date
    C0332575 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Redness - medically attended visit?
    Item
    Redness - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [1,3])
    Item
    Redness - specify medically attended visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Redness - specify medically attended visit
    Code List
    Redness - specify medically attended visit
    CL Item
    Hospitalization  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Swelling
    Item
    Swelling
    boolean
    C0038999 (UMLS CUI [1])
    Size of swelling Day 0
    Item
    If swelling, enter size at Day 0
    integer
    C0456389 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of swelling Day 1
    Item
    If swelling, enter size at Day 1
    integer
    C0456389 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of swelling Day 2
    Item
    If swelling, enter size at Day 2
    integer
    C0456389 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Size of swelling Day 3
    Item
    If swelling, enter size at Day 3
    integer
    C0456389 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Swelling ongoing after day 3?
    Item
    Swelling ongoing after day 3?
    boolean
    C0038999 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of swelling
    Item
    Date of last day of swelling
    date
    C0038999 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Swelling - medically attended visit?
    Item
    Swelling - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [1,3])
    Item
    Swelling - specify medically attended visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Sewlling - specify medically attended visit
    Code List
    Swelling - specify medically attended visit
    CL Item
    Hospitalization  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Pain
    Item
    Pain
    boolean
    C0030193 (UMLS CUI [1])
    Item
    If pain, enter Intensity at Day 0
    integer
    C1320357 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Intensity of pain Day 0
    Code List
    If pain, enter Intensity at Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    If pain, enter Intensity at Day 1
    integer
    C1320357 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Intensity of pain Day 1
    Code List
    If pain, enter Intensity at Day 1
    CL Item
    None (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    If pain, enter Intensity at Day 2
    integer
    C1320357 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Intensity of pain Day 2
    Code List
    If pain, enter Intensity at Day 2
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    If pain, enter Intensity at Day 3
    integer
    C1320357 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Intensity of pain Day 3
    Code List
    If pain, enter Intensity at Day 3
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Pain ongoing after day 3?
    Item
    Pain ongoing after day 3?
    boolean
    C0030193 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of pain
    Item
    Date of last day of pain
    date
    C0030193 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Pain - medically attended visit?
    Item
    Pain - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    Item
    Pain - specify medically attended visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Pain - specify medically attended visit
    Code List
    Pain - specify medically attended visit
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency Room (ER)
    CL Item
    Medical Personnel (MD)
    Item Group
    Soliced Adverse Events - General Symptoms
    C0877248 (UMLS CUI-1)
    C0159028 (UMLS CUI-2)
    Item
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    text
    C0037088 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0042210 (UMLS CUI [1,4])
    Signs/symptoms during the solicited period
    Code List
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    CL Item
    Information not available (U)
    CL Item
    No vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/ Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Item
    General Symptoms
    text
    C0159028 (UMLS CUI [1])
    General Symptoms
    Code List
    General Symptoms
    CL Item
    Fever (FE)
    CL Item
    Irritability/ Fussiness (IR)
    CL Item
    Drowsiness (DR)
    CL Item
    Loss of appetite (LO)
    Fever - Body temperature Day 0
    Item
    Fever - Body temperature Day 0
    float
    C0039476 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Fever - Body temperature Day 0 not taken
    integer
    C0437722 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Fever - Body temperature Day 0 not taken
    Code List
    Fever - Body temperature Day 0 not taken
    CL Item
    not taken (1)
    Fever - Body temperature Day 1
    Item
    Fever - Body temperature Day 1
    float
    C0039476 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Fever - Body temperature Day 1 not taken
    integer
    C0437722 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Fever - Body temperature Day 1 not taken
    Code List
    Fever - Body temperature Day 1 not taken
    CL Item
    not taken (1)
    Fever - Body temperature Day 2
    Item
    Fever - Body temperature Day 2
    float
    C0039476 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Fever - Body temperature Day 2 not taken
    integer
    C0437722 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Fever - Body temperature Day 2 not taken
    Code List
    Fever - Body temperature Day 2 not taken
    CL Item
    not taken (1)
    Fever - Body temperature Day 3
    Item
    Fever - Body temperature Day 3
    float
    C0039476 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Fever - Body temperature Day 3 not taken
    integer
    C0437722 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Fever - Body temperature Day 3 not taken
    Code List
    Fever - Body temperature Day 3 not taken
    CL Item
    not taken (1)
    Is fever ongoing after day 3?
    Item
    Is fever ongoing after day 3?
    boolean
    C0015967 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of fever.
    Item
    Date of last day of fever.
    date
    C0015967 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Fever - Causality?
    Item
    Fever - Causality?
    boolean
    C0015967 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Fever - medically attended visit?
    Item
    Fever - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    Item
    Fever - specify medically attended visit.
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Fever - specify medically attended visit
    Code List
    Fever - specify medically attended visit.
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency Room (ER)
    CL Item
    Medical Personnel (MD)
    Item
    Irritability/ Fussiness - Intensity Day 0
    integer
    C0022107 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Irritability/ Fussiness - Intensity Day 0
    Code List
    Irritability/ Fussiness - Intensity Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Irritability/ Fussiness - Intensity Day 1
    integer
    C0022107 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Irritability/ Fussiness - Intensity Day 1
    Code List
    Irritability/ Fussiness - Intensity Day 1
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Irritability/ Fussiness - Intensity Day 2
    integer
    C0022107 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Irritability/ Fussiness - Intensity Day 2
    Code List
    Irritability/ Fussiness - Intensity Day 2
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Irritability/ Fussiness - Intensity Day 3
    integer
    C0022107 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Irritability/ Fussiness - Intensity Day 3
    Code List
    Irritability/ Fussiness - Intensity Day 3
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Is irritability/ fussiness ongoing after day 3?
    Item
    Is irritability/ fussiness ongoing after day 3?
    boolean
    C0022107 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of irritability/ fussiness.
    Item
    Date of last day of irritability/ fussiness.
    date
    C0022107 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Irritability/ Fussiness- Causality?
    Item
    Irritability/ Fussiness- Causality?
    boolean
    C0022107 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Irritability/ Fussiness- medically attended visit?
    Item
    Irritability/Fussiness - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0022107 (UMLS CUI [1,3])
    Item
    Irritability/ Fussiness- specify medically attended visit.
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0022107 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Irritability/ Fussiness - specify medically attended visit
    Code List
    Irritability/ Fussiness- specify medically attended visit.
    CL Item
    Hospitalization  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Item
    Drowsiness - Intensity Day 0
    integer
    C0013144 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Drowsiness - Intensity Day 0
    Code List
    Drowsiness - Intensity Day 0
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Drowsiness - Intensity Day 1
    integer
    C0013144 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Drowsiness - Intensity Day 1
    Code List
    Drowsiness - Intensity Day 1
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Drowsiness - Intensity Day 2
    integer
    C0013144 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Drowsiness - Intensity Day 2
    Code List
    Drowsiness - Intensity Day 2
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Drowsiness - Intensity Day 3
    integer
    C0013144 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Drowsiness - Intensity Day 3
    Code List
    Drowsiness - Intensity Day 3
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Is drowsiness ongoing after day 3?
    Item
    Is drowsiness ongoing after day 3?
    boolean
    C0013144 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of drowsiness.
    Item
    Date of last day of drowsiness.
    date
    C0013144 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Drowsiness - Causality?
    Item
    Drowsiness - Causality?
    boolean
    C0013144 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Drowsiness - medically attended visit?
    Item
    Drowsiness - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [1,3])
    Item
    Drowsiness - specify medically attended visit.
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Drowsiness - specify medically attended visit
    Code List
    Drowsiness - specify medically attended visit.
    CL Item
    Hospitalization  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Item
    Loss of appetite - Intensity Day 0
    integer
    C1971624 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Loss of appetite - Intensity Day 0
    Code List
    Loss of appetite - Intensity Day 0
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite - Intensity Day 1
    integer
    C1971624 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Loss of appetite - Intensity Day 1
    Code List
    Loss of appetite - Intensity Day 1
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite - Intensity Day 2
    integer
    C1971624 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Loss of appetite - Intensity Day 2
    Code List
    Loss of appetite - Intensity Day 2
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite - Intensity Day 3
    integer
    C1971624 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Loss of appetite - Intensity Day 3
    Code List
    Loss of appetite - Intensity Day 3
    CL Item
    None  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Is loss of appetite ongoing after day 3?
    Item
    Is loss of appetite ongoing after day 3?
    boolean
    C1971624 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    If loss of appetite is ongoing after day 3, record date of last day of symptoms.
    Item
    Date of last day of loss of appetite.
    date
    C1971624 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Loss of appetite - Causality?
    Item
    Loss of appetite - Causality?
    boolean
    C1971624 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Loss of appetite - medically attended visit?
    Item
    Loss of appetite - medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [1,3])
    Item
    Loss of appetite - specify medically attended visit.
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Loss of appetite - specify medically attended visit
    Code List
    Loss of appetite - specify medically attended visit.
    CL Item
    Hospitalization  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    In case of intensity 3: Was the crying continuous
    Item
    In case of intensity 3: Was the crying continuous (i.e. episodic, not interrupted within the time period of 3 hours by e.g. naps)?
    boolean
    C0518690 (UMLS CUI [1])
    C2721683 (UMLS CUI [2])
    In case of intensity 3: was the crying unaltered >=3 hours?
    Item
    In case of intensity 3: was the crying unaltered >=3 hours?
    boolean
    C0518690 (UMLS CUI [1,1])
    C0438697 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
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