0 Evaluaciones
ID

27324

Descripción

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Palabras clave

Versiones (1)
  1. 8/11/17 8/11/17 -
Titular de derechos de autor

Pfizer

Subido en

8 de noviembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Meningococcal Infections Vaccination in children NCT00196976

    Inglés

    Diary Card Part 2 Vaccination 1 3-5 years of age

    1 formularios  
    Administrative Documentation
    Descripción

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
    Descripción

    Date Diary Card return

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0545082
    UMLS CUI [1,4]
    C1548100
    SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
    Descripción

    SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

    Alias
    UMLS CUI-1
    C0159028
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0877248
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    Descripción

    Signs and Symptoms

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0037088
    Fever
    Descripción

    Fever

    Alias
    UMLS CUI-1
    C0015967
    Fever
    Descripción

    Fever

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Location of fever measurement
    Descripción

    Location of fever measurement

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0449687
    UMLS CUI [1,2]
    C0015967
    Fever Day 0
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 1 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 2 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 3 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 4 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 5 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 6 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Fever Day 7 Evening
    Descripción

    Fever

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0015967
    °C
    Ongoing after day 7?
    Descripción

    Ongoing symptom

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C3174772
    UMLS CUI [1,3]
    C0015967
    Date of last day of symptoms
    Descripción

    Date of last day of symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0015967
    Medically attended visit
    Descripción

    Medically attended visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
    Irritability
    Descripción

    Irritability

    Alias
    UMLS CUI-1
    C0022107
    Irritability/ Fussiness
    Descripción

    Irritability

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0022107
    Irritability/Fussiness Intensity Day 0
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of Irritability/fussiness Day 1 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of Irritability/fussiness Day 2 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of irritability/fussiness day 3 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of irritability/fussiness day 4 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of irritability/fussiness Day 5 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of irritability/fussiness Day 6 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Intensity of irritability/fussiness Day 7 Evening
    Descripción

    Intensity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0022107
    Ongoing after day 7?
    Descripción

    Ongoing symptom

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C3174772
    UMLS CUI [1,3]
    C0022107
    Date of last day of symptoms
    Descripción

    Date of last day of symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0022107
    Medically attended visit
    Descripción

    Medically attended visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [1,4]
    C0022107
    Drowsiness
    Descripción

    Drowsiness

    Alias
    UMLS CUI-1
    C0013144
    Drowsiness
    Descripción

    Drowsiness

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness Intensity Day 0
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 1 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of drowsiness Day 2 Evening
    Descripción

    Intensity of drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 3 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 4 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 5 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 6 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Intensity of Drowsiness Day 7 Evening
    Descripción

    Intensity of Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Ongoing after day 7?
    Descripción

    Ongoing symptom?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C3174772
    UMLS CUI [1,3]
    C0013144
    Date of last day of symptoms
    Descripción

    Date of last day of symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013144
    Medically attended visit
    Descripción

    Medically attended visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0013144
    IN CASE OF HOSPITALISATION, PLEASE INFORM
    Descripción

    Contact information

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1880174
    UMLS CUI [1,2]
    C0019993
    Loss of appetite
    Descripción

    Loss of appetite

    Alias
    UMLS CUI-1
    C1971624
    Loss of appetite
    Descripción

    Loss of appetite

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1971624
    Loss of appetite, Intensity Day 0
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 1 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity day 2 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 3 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 4 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 5 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 6 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite, Intensity Day 7 Evening
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Ongoing after day 7?
    Descripción

    Ongoing symptom

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C3174772
    UMLS CUI [1,3]
    C1971624
    Date of last day of symptoms
    Descripción

    Date of last day of symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1971624
    Medically attended visit
    Descripción

    Medically attended visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1971624
    Other General Symptoms (Day 0 to day 30)
    Descripción

    Other General Symptoms (Day 0 to day 30)

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

    Description

    Tipo de datos

    text

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

    Intensity

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1710066
    UMLS CUI [1,2]
    C0159028
    Start date
    Descripción

    Start date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0159028
    End date
    Descripción

    End date

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0159028
    Check box if continuing
    Descripción

    Ongoing Symptom

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0159028
    UMLS CUI [1,2]
    C3174772
    Medically attended visit
    Descripción

    Medically attended visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0159028
    Medication - Please fill in below if any medication has been taken since the vaccination
    Descripción

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

    Alias
    UMLS CUI-1
    C0013227
    Trade/Generic name
    Descripción

    Medication

    Tipo de datos

    text

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

    Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Total Daily Dose
    Descripción

    Total Daily Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Start date
    Descripción

    Start date

    Tipo de datos

    date

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

    End date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Check box if continuing
    Descripción

    Ongoing medication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    Similar models

    Diary Card Part 2 Vaccination 1 3-5 years of age

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Documentation
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date Diary Card return
    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])
    Item Group
    SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
    C0159028 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    text
    C0037088 (UMLS CUI [1])
    Signs and Symptoms
    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 Group
    Fever
    C0015967 (UMLS CUI-1)
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Item
    Location of fever measurement
    text
    C0449687 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Location of fever measurement
    Code List
    Location of fever measurement
    CL Item
    Axillary (A)
    CL Item
    rectal (R)
    Fever
    Item
    Fever Day 0
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 1 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 2 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 3 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 4 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 5 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 6 Evening
    float
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever Day 7 Evening
    float
    C0015967 (UMLS CUI [1])
    Ongoing symptom
    Item
    Ongoing after day 7?
    boolean
    C1457887 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    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
    Irritability
    C0022107 (UMLS CUI-1)
    Irritability
    Item
    Irritability/ Fussiness
    boolean
    C0022107 (UMLS CUI [1])
    Item
    Irritability/Fussiness Intensity Day 0
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Irritability/Fussiness Intensity Day 0
    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
    Intensity of Irritability/fussiness Day 1 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of Irritability/fussiness Day 1 Evening
    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
    Intensity of Irritability/fussiness Day 2 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of Irritability/fussiness Day 2 Evening
    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
    Intensity of irritability/fussiness day 3 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of irritability/fussiness day 3 Evening
    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
    Intensity of irritability/fussiness day 4 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of irritability/fussiness day 4 Evening
    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
    Intensity of irritability/fussiness Day 5 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of irritability/fussiness Day 5 Evening
    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
    Intensity of irritability/fussiness Day 6 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of irritability/fussiness Day 6 Evening
    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
    Intensity of irritability/fussiness Day 7 Evening
    integer
    C0518690 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Intensity
    Code List
    Intensity of irritability/fussiness Day 7 Evening
    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)
    Ongoing symptom
    Item
    Ongoing after day 7?
    boolean
    C1457887 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    C0022107 (UMLS CUI [1,3])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0022107 (UMLS CUI [1,4])
    Item Group
    Drowsiness
    C0013144 (UMLS CUI-1)
    Drowsiness
    Item
    Drowsiness
    boolean
    C0013144 (UMLS CUI [1])
    Item
    Drowsiness Intensity Day 0
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Drowsiness Intensity Day 0
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 1 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 1 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of drowsiness Day 2 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of drowsiness
    Code List
    Intensity of drowsiness Day 2 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 3 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 3 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 4 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 4 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 5 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 5 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 6 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 6 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    Intensity of Drowsiness Day 7 Evening
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Intensity of Drowsiness
    Code List
    Intensity of Drowsiness Day 7 Evening
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Ongoing symptom?
    Item
    Ongoing after day 7?
    boolean
    C1457887 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [1,3])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0013144 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [1,3])
    Contact information
    Item
    IN CASE OF HOSPITALISATION, PLEASE INFORM
    text
    C1880174 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Item Group
    Loss of appetite
    C1971624 (UMLS CUI-1)
    Loss of appetite
    Item
    Loss of appetite
    boolean
    C1971624 (UMLS CUI [1])
    Item
    Loss of appetite, Intensity Day 0
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 0
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 1 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 1 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity day 2 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity day 2 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 3 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 3 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 4 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 4 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 5 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 5 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 6 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 6 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    Loss of appetite, Intensity Day 7 Evening
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    Loss of appetite, Intensity Day 7 Evening
    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 normal activity (2)
    CL Item
    Not eating at all (3)
    Ongoing symptom
    Item
    Ongoing after day 7?
    boolean
    C1457887 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [1,3])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C1971624 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [1,3])
    Item Group
    Other General Symptoms (Day 0 to day 30)
    C0029625 (UMLS CUI-1)
    Description
    Item
    Description - please give details below
    text
    C0678257 (UMLS CUI [1,1])
    C0029625 (UMLS CUI [1,2])
    Item
    Intensity
    text
    C1710066 (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 [1,1])
    C0159028 (UMLS CUI [1,2])
    End date
    Item
    End date
    text
    C0806020 (UMLS CUI [1,1])
    C0159028 (UMLS CUI [1,2])
    Ongoing Symptom
    Item
    Check box if continuing
    boolean
    C0159028 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0159028 (UMLS CUI [1,3])
    Item Group
    Medication - Please fill in below if any medication has been taken since the vaccination
    C0013227 (UMLS CUI-1)
    Medication
    Item
    Trade/Generic name
    text
    C0013227 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Start date
    Item
    Start date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date
    Item
    End date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Ongoing medication
    Item
    Check box if continuing
    boolean
    C2826666 (UMLS CUI [1])
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