0 Ratings
ID

30027

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 Documentation part: Visit 4, Month 3,5, 28-42 days after Visit 3, Dose 3

Keywords

Versions (3)
  1. 7/10/17 7/10/17 -
  2. 7/10/17 7/10/17 -
  3. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 4 759346/004

    English

    Visit 4 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 forms  
    Check for Study Continuation
    Description

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0042210
    Did the subject come at visit 4 ?
    Description

    subject return for visit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Description

    If No, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    SAE Number
    Description

    If Serious adverse event, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    AE Number or Code
    Description

    If Non-serious adverse event, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Other reason for Study Discontinuation
    Description

    If Other, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    reason for study discontinuation
    Description

    reason for study discontinuation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    Pre-Vaccination Assessment
    Description

    Pre-Vaccination Assessment

    Alias
    UMLS CUI-1
    C0220825
    UMLS CUI-2
    C0005903
    UMLS CUI-3
    C0042196
    Temperature
    Description

    Route: Axillary

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Vaccine Administration, Dose 3, Tritanrix-HepB/Hib-MenAC Vaccine
    Description

    Vaccine Administration, Dose 3, Tritanrix-HepB/Hib-MenAC Vaccine

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0700144
    UMLS CUI-4
    C2240392
    Date of Vaccine Administration
    Description

    Please complete only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Vaccine Administration
    Description

    Vaccine Administration

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2368628
    Wrong vial number
    Description

    If Wrong vial number, please specify number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0184301
    Administration Side
    Description

    Left

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Administration Site
    Description

    Anterolateral thigh

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Administration Route
    Description

    I.M.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Please tick the major reason for non administration
    Description

    If not administered

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Serious adverse event Number
    Description

    If reason for non administration = Serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Non-serious adverse event Number
    Description

    If reason for non administration = Non-serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    reason for non administration, if other please specify
    Description

    reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Please tick who made the decision
    Description

    non administration

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Has the study vaccine been administered according to the Protocol ?
    Description

    Study vaccine Administration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2368628
    Study vaccine Administration: Side
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Study vaccine Administration: Site
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Study vaccine Administration: Route
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Vaccine Administration - Dose 3 - Tritanrix-HepB/Hib Vaccine OR MenC Vaccine
    Description

    Vaccine Administration - Dose 3 - Tritanrix-HepB/Hib Vaccine OR MenC Vaccine

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0700144
    UMLS CUI-4
    C2240392
    Date of Vaccine Administration
    Description

    Please complete only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Vaccine Administration
    Description

    If "Tritanrix-HepB/Hib-MenAC Vaccine (lot 1 or 2 or 3)" was not administered

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2368628
    Wrong vial number
    Description

    If Wrong vial number, please specify number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0184301
    Administration Side
    Description

    Left

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Administration Site
    Description

    Anterolateral thigh

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Administration Route
    Description

    I.M.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Please tick the major reason for non administration
    Description

    If not administered

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Serious adverse event Number
    Description

    If reason for non administration = Serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Non-serious adverse event Number
    Description

    If reason for non administration = Non-serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    reason for non administration, if other please specify
    Description

    reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Please tick who made the decision
    Description

    non administration

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Has the study vaccine been administered according to the Protocol ?
    Description

    Study vaccine Administration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2368628
    Study vaccine Administration: Side
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Study vaccine Administration: Site
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Study vaccine Administration: Route
    Description

    Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Adverse Events, Post-Vaccination Observation
    Description

    Adverse Events, Post-Vaccination Observation

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C0700325
    UMLS CUI-3
    C0877248
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
    Description

    serious or non-serious unsolicited adverse events

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C0877248
    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine
    Description

    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    UMLS CUI-3
    C0042196
    UMLS CUI-4
    C0877248
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hib-MenAC vaccine
    Description

    Tritanrix-HepB/Hib-MenAC vaccine

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0042196
    Redness
    Description

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C2700396
    Redness, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Redness on Day 0
    Description

    Redness on Day 0

    Data type

    float

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

    Redness on Day 1

    Data type

    float

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

    Redness on Day 2

    Data type

    float

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

    Redness on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Redness ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0332575
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0332575
    Swelling
    Description

    Swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C2700396
    Swelling, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Swelling on Day 0
    Description

    Swelling on Day 0

    Data type

    float

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

    Swelling on Day 1

    Data type

    float

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

    Swelling on Day 2

    Data type

    float

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

    Swelling on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Swelling ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0038999
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0038999
    Pain
    Description

    Pain

    Data type

    boolean

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

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain on Day 0
    Description

    Pain on Day 0

    Data type

    integer

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

    Pain on Day 1

    Data type

    integer

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

    Pain on Day 2

    Data type

    integer

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

    Pain on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain ongoing after day 3?
    Description

    Pain ongoing after day 3

    Data type

    boolean

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

    Pain ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0030193
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0030193
    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine
    Description

    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    UMLS CUI-3
    C2240392
    UMLS CUI-4
    C0877248
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hib vaccine
    Description

    Tritanrix-HepB/Hib vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C2240392
    Redness
    Description

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C2700396
    Redness, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Redness on Day 0
    Description

    Redness on Day 0

    Data type

    float

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

    Redness on Day 1

    Data type

    float

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

    Redness on Day 2

    Data type

    float

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

    Redness on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Redness ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0332575
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0332575
    Swelling
    Description

    Swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C2700396
    Swelling, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Swelling on Day 0
    Description

    Swelling on Day 0

    Data type

    float

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

    Swelling on Day 1

    Data type

    float

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

    Swelling on Day 2

    Data type

    float

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

    Swelling on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Swelling ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0038999
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0038999
    Pain
    Description

    Pain

    Data type

    boolean

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

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain on Day 0
    Description

    Pain on Day 0

    Data type

    integer

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

    Pain on Day 1

    Data type

    integer

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

    Pain on Day 2

    Data type

    integer

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

    Pain on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain ongoing after day 3?
    Description

    Pain ongoing after day 3

    Data type

    boolean

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

    Pain ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0030193
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0030193
    Solicited Adverse Events - Local Symptoms - MenC vaccine
    Description

    Solicited Adverse Events - Local Symptoms - MenC vaccine

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    UMLS CUI-3
    C0700144
    UMLS CUI-4
    C0877248
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? MenC vaccine
    Description

    MenC vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0700144
    Redness
    Description

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C2700396
    Redness, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Redness on Day 0
    Description

    Redness on Day 0

    Data type

    float

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

    Redness on Day 1

    Data type

    float

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

    Redness on Day 2

    Data type

    float

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

    Redness on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Redness ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0332575
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0332575
    Swelling
    Description

    Swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C2700396
    Swelling, size (mm)
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    mm
    Swelling on Day 0
    Description

    Swelling on Day 0

    Data type

    float

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

    Swelling on Day 1

    Data type

    float

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

    Swelling on Day 2

    Data type

    float

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

    Swelling on Day 3

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C2700396
    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]
    C2700396
    Date of last day of symptoms
    Description

    Swelling ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0038999
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0038999
    Pain
    Description

    Pain

    Data type

    boolean

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

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain on Day 0
    Description

    Pain on Day 0

    Data type

    integer

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

    Pain on Day 1

    Data type

    integer

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

    Pain on Day 2

    Data type

    integer

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

    Pain on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C2700396
    Pain ongoing after day 3?
    Description

    Pain ongoing after day 3

    Data type

    boolean

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

    Pain ongoing after day 3? If 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
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0030193
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0030193
    Solicited Adverse Events - General Symptoms
    Description

    Solicited Adverse Events - General Symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0877248
    Fever
    Description

    Axillary ≥ 37.5°C Oral ≥ 37.5°C Tympanic (oral conversion) ≥ 37.5°C Tympanic (rectal conversion) ≥ 38°C Rectal ≥ 38°C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Fever
    Description

    If Yes, please specify

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1]
    C0015967
    C
    Fever, Site of measurement
    Description

    Site of measurement

    Data type

    text

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

    Fever on Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Fever on Day 0
    Description

    if taken, please specify

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Fever on Day 1
    Description

    Fever on Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Fever on Day 1
    Description

    if taken, please specify

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Fever on Day 2
    Description

    Fever on Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Fever on Day 2
    Description

    if taken, please specify

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Fever on Day 3
    Description

    Fever on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Fever on Day 3
    Description

    if taken, please specify

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Fever ongoing after day 3?
    Description

    Fever ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Date of last day of symptoms
    Description

    Fever ongoing after day 3? If Yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0015967
    Causality?
    Description

    Causality

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015127
    UMLS CUI [2]
    C0015967
    Medically attended visit
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0015967
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0015967
    Irritability/Fussiness
    Description

    Irritability/Fussiness

    Data type

    boolean

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

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0522510
    In case of intensity 3: was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
    Description

    Irritability / Fussiness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0438697
    In case of intensity 3: was the crying unaltered for > 3 hours ?
    Description

    Irritability / Fussiness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0438697
    UMLS CUI [1,2]
    C0449238
    Irritability/Fussiness on Day 0
    Description

    Irritability/Fussiness on Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022107
    Irritability/Fussiness on Day 1
    Description

    Irritability/Fussiness on Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022107
    Irritability/Fussiness on Day 2
    Description

    Irritability/Fussiness on Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022107
    Irritability/Fussiness on Day 3
    Description

    Irritability/Fussiness on Day 3

    Data type

    integer

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

    Irritability/Fussiness ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022107
    Date of last day of symptoms
    Description

    Irritability/Fussiness ongoing after day 3? If Yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0011008
    Causality
    Description

    Causality

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015127
    UMLS CUI [2]
    C0022107
    Medically attended visit
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0022107
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

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

    Drowsiness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness, Intensity
    Description

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    Drowsiness on Day 0
    Description

    Drowsiness on Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness on Day 1
    Description

    Drowsiness on Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness on Day 2
    Description

    Drowsiness on Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness on Day 3
    Description

    Drowsiness on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013144
    Drowsiness ongoing after day 3?
    Description

    Drowsiness ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013144
    Date of last day of symptoms
    Description

    Drowsiness ongoing after day 3? If Yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0011008
    Causality?
    Description

    Causality

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015127
    UMLS CUI [2]
    C0013144
    Medically attended visit
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C0013144
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C0013144
    Loss of appetite
    Description

    Loss of appetite

    Data type

    boolean

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

    If Yes, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    Loss of appetite on Day 0
    Description

    Loss of appetite on Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1971624
    Loss of appetite on Day 1
    Description

    Loss of appetite on Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1971624
    Loss of appetite on Day 2
    Description

    Loss of appetite on Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1971624
    Loss of appetite on Day 3
    Description

    Loss of appetite on Day 3

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1971624
    Loss of appetite ongoing after day 3?
    Description

    Loss of appetite ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1971624
    Date of last day of symptoms
    Description

    Loss of appetite ongoing after day 3? If Yes, please specify

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0011008
    Causality?
    Description

    Causality

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015127
    UMLS CUI [2]
    C1971624
    Medically attended visit
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C1971624
    Medically attended visit Type
    Description

    Medically attended visit Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C1971624
    Back to the top of the page

    Similar models

    Visit 4 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    Item
    Did the subject come at visit 4 ?
    integer
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    subject return for visit 2
    Code List
    Did the subject come at visit 4 ?
    CL Item
    Yes, please complete the next pages. (1)
    CL Item
    No, please specify (2)
    Item
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    integer
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    reason for study discontinuation
    Code List
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse Event (1)
    CL Item
    Non-Serious adverse Event (2)
    CL Item
    Other (3)
    SAE Number
    Item
    SAE Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE Number
    Item
    AE Number or Code
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Other reason for Study Discontinuation
    Item
    Other reason for Study Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item
    reason for study discontinuation
    integer
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    non administration
    Code List
    reason for study discontinuation
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (2)
    Item Group
    Pre-Vaccination Assessment
    C0220825 (UMLS CUI-1)
    C0005903 (UMLS CUI-2)
    C0042196 (UMLS CUI-3)
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Vaccine Administration, Dose 3, Tritanrix-HepB/Hib-MenAC Vaccine
    C2368628 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0700144 (UMLS CUI-3)
    C2240392 (UMLS CUI-4)
    Date of Vaccine Administration
    Item
    Date of Vaccine Administration
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Item
    Vaccine Administration
    integer
    C2368628 (UMLS CUI [1])
    Vaccine Administration
    Code List
    Vaccine Administration
    CL Item
    Tritanrix-HepB/Hib-MenAC Vaccine (lot 1 or 2 or 3) (1)
    CL Item
    Replacement vial  (2)
    CL Item
    Wrong vial number (3)
    CL Item
    Not administered (4)
    Wrong vial number
    Item
    Wrong vial number
    integer
    C0184301 (UMLS CUI [1])
    Administration Side
    Item
    Administration Side
    text
    C0441987 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Administration Site
    Item
    Administration Site
    text
    C1515974 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Administration Route
    Item
    Administration Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Item
    Please tick the major reason for non administration
    integer
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    reason for non administration
    Code List
    Please tick the major reason for non administration
    CL Item
    Serious adverse event (1)
    CL Item
    Non-Serious adverse event (2)
    CL Item
    Other (3)
    Serious adverse event Number
    Item
    Serious adverse event Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Non-serious adverse event Number
    Item
    Non-serious adverse event Number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    reason for non administration
    Item
    reason for non administration, if other please specify
    text
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    Please tick who made the decision
    integer
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    non administration
    Code List
    Please tick who made the decision
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (2)
    Study vaccine Administration
    Item
    Has the study vaccine been administered according to the Protocol ?
    boolean
    C2368628 (UMLS CUI [1])
    Item
    Study vaccine Administration: Side
    integer
    C0441987 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Study vaccine Administration Side
    Code List
    Study vaccine Administration: Side
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    Study vaccine Administration: Site
    integer
    C1515974 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Study vaccine Administration Site
    Code List
    Study vaccine Administration: Site
    CL Item
    Deltoid (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item
    Study vaccine Administration: Route
    integer
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Study vaccine Administration Route
    Code List
    Study vaccine Administration: Route
    CL Item
    I.M. (1)
    CL Item
    S.C. (2)
    Item Group
    Vaccine Administration - Dose 3 - Tritanrix-HepB/Hib Vaccine OR MenC Vaccine
    C2368628 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0700144 (UMLS CUI-3)
    C2240392 (UMLS CUI-4)
    Date of Vaccine Administration
    Item
    Date of Vaccine Administration
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Item
    Vaccine Administration
    integer
    C2368628 (UMLS CUI [1])
    Vaccine Administration
    Code List
    Vaccine Administration
    CL Item
    Tritanrix™-HepB/Hib Vaccine (1)
    CL Item
    MenC Vaccine (2)
    CL Item
    Replacement vial (3)
    CL Item
    Wrong vial number  (4)
    CL Item
    Not administered (5)
    Wrong vial number
    Item
    Wrong vial number
    integer
    C0184301 (UMLS CUI [1])
    Administration Side
    Item
    Administration Side
    text
    C0441987 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Administration Site
    Item
    Administration Site
    text
    C1515974 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Administration Route
    Item
    Administration Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Item
    Please tick the major reason for non administration
    integer
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    reason for non administration
    Code List
    Please tick the major reason for non administration
    CL Item
    Serious adverse event (1)
    CL Item
    Non-Serious adverse event (2)
    CL Item
    Other (3)
    Serious adverse event Number
    Item
    Serious adverse event Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Non-serious adverse event Number
    Item
    Non-serious adverse event Number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    reason for non administration
    Item
    reason for non administration, if other please specify
    text
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    Please tick who made the decision
    integer
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    non administration
    Code List
    Please tick who made the decision
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (2)
    Study vaccine Administration
    Item
    Has the study vaccine been administered according to the Protocol ?
    boolean
    C2368628 (UMLS CUI [1])
    Item
    Study vaccine Administration: Side
    integer
    C0441987 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Study vaccine Administration Side
    Code List
    Study vaccine Administration: Side
    CL Item
    Left (1)
    CL Item
    Right (2)
    Item
    Study vaccine Administration: Site
    integer
    C1515974 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Study vaccine Administration Site
    Code List
    Study vaccine Administration: Site
    CL Item
    Deltoid (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item
    Study vaccine Administration: Route
    integer
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Study vaccine Administration Route
    Code List
    Study vaccine Administration: Route
    CL Item
    I.M. (1)
    CL Item
    S.C. (2)
    Item Group
    Adverse Events, Post-Vaccination Observation
    C0042196 (UMLS CUI-1)
    C0700325 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
    integer
    C0042196 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    serious or non-serious unsolicited adverse events
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
    CL Item
    Information not retrievable (1)
    CL Item
    No (2)
    CL Item
    Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)
    CL Item
    No Vaccine administered (4)
    Item Group
    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    C0042196 (UMLS CUI-3)
    C0877248 (UMLS CUI-4)
    Item
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hib-MenAC vaccine
    text
    C1457887 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    symptoms
    Code List
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hib-MenAC vaccine
    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 [1,1])
    C2700396 (UMLS CUI [1,2])
    Redness
    Item
    Redness, size (mm)
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 0
    Item
    Redness on Day 0
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 1
    Item
    Redness on Day 1
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 2
    Item
    Redness on Day 2
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 3
    Item
    Redness on Day 3
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness ongoing after day 3
    Item
    Redness ongoing after day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332575 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Swelling
    Item
    Swelling
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Swelling
    Item
    Swelling, size (mm)
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 0
    Item
    Swelling on Day 0
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 1
    Item
    Swelling on Day 1
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 2
    Item
    Swelling on Day 2
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 3
    Item
    Swelling on Day 3
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling ongoing after day 3
    Item
    Swelling ongoing after day 3?
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Pain
    Item
    Pain
    boolean
    C0030193 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Item
    Pain, intensity
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain, intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 0
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 1
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 2
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 3
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on 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])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0030193 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Item Group
    Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    C2240392 (UMLS CUI-3)
    C0877248 (UMLS CUI-4)
    symptoms
    Item
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hib vaccine
    boolean
    C1457887 (UMLS CUI [1,1])
    C2240392 (UMLS CUI [1,2])
    Redness
    Item
    Redness
    boolean
    C0332575 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Redness
    Item
    Redness, size (mm)
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 0
    Item
    Redness on Day 0
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 1
    Item
    Redness on Day 1
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 2
    Item
    Redness on Day 2
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 3
    Item
    Redness on Day 3
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness ongoing after day 3
    Item
    Redness ongoing after day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332575 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Swelling
    Item
    Swelling
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Swelling
    Item
    Swelling, size (mm)
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 0
    Item
    Swelling on Day 0
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 1
    Item
    Swelling on Day 1
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 2
    Item
    Swelling on Day 2
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 3
    Item
    Swelling on Day 3
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling ongoing after day 3
    Item
    Swelling ongoing after day 3?
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Pain
    Item
    Pain
    boolean
    C0030193 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Item
    Pain, intensity
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain, intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 0
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 1
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 2
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 3
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on 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])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0030193 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Item Group
    Solicited Adverse Events - Local Symptoms - MenC vaccine
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    C0700144 (UMLS CUI-3)
    C0877248 (UMLS CUI-4)
    symptoms
    Item
    For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? MenC vaccine
    boolean
    C1457887 (UMLS CUI [1,1])
    C0700144 (UMLS CUI [1,2])
    Redness
    Item
    Redness
    boolean
    C0332575 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Redness
    Item
    Redness, size (mm)
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 0
    Item
    Redness on Day 0
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 1
    Item
    Redness on Day 1
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 2
    Item
    Redness on Day 2
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness on Day 3
    Item
    Redness on Day 3
    float
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Redness ongoing after day 3
    Item
    Redness ongoing after day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0332575 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332575 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Swelling
    Item
    Swelling
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Swelling
    Item
    Swelling, size (mm)
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 0
    Item
    Swelling on Day 0
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 1
    Item
    Swelling on Day 1
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 2
    Item
    Swelling on Day 2
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling on Day 3
    Item
    Swelling on Day 3
    float
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Swelling ongoing after day 3
    Item
    Swelling ongoing after day 3?
    boolean
    C0038999 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Pain
    Item
    Pain
    boolean
    C0030193 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    Item
    Pain, intensity
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain, intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 0
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 1
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 2
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Pain on Day 3
    integer
    C0030193 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Pain
    Code List
    Pain on 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])
    C2700396 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0030193 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Item Group
    Solicited Adverse Events - General Symptoms
    C1457887 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Fever
    Item
    Fever
    float
    C0015967 (UMLS CUI [1])
    Item
    Fever, Site of measurement
    text
    C0449687 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Site of measurement
    Code List
    Fever, Site of measurement
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    Item
    Fever on Day 0
    integer
    C0015967 (UMLS CUI [1])
    Fever on Day 0
    Code List
    Fever on Day 0
    CL Item
    taken (1)
    CL Item
    not taken (2)
    Fever on Day 0
    Item
    Fever on Day 0
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Item
    Fever on Day 1
    integer
    C0015967 (UMLS CUI [1])
    Fever on Day 0
    Code List
    Fever on Day 1
    CL Item
    taken (1)
    CL Item
    not taken (2)
    Fever on Day 1
    Item
    Fever on Day 1
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Item
    Fever on Day 2
    integer
    C0015967 (UMLS CUI [1])
    Fever on Day 0
    Code List
    Fever on Day 2
    CL Item
    taken (1)
    CL Item
    not taken (2)
    Fever on Day 2
    Item
    Fever on Day 2
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Item
    Fever on Day 3
    integer
    C0015967 (UMLS CUI [1])
    Fever on Day 0
    Code List
    Fever on Day 3
    CL Item
    taken (1)
    CL Item
    not taken (2)
    Fever on Day 3
    Item
    Fever on Day 3
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Fever ongoing after day 3
    Item
    Fever ongoing after day 3?
    boolean
    C0015967 (UMLS CUI [1])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Causality
    Item
    Causality?
    boolean
    C0015127 (UMLS CUI [1])
    C0015967 (UMLS CUI [2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0015967 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Irritability/Fussiness
    Item
    Irritability/Fussiness
    boolean
    C0022107 (UMLS CUI [1])
    Item
    Irritability/Fussiness, Intensity
    integer
    C0022107 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Pain
    Code List
    Irritability/Fussiness, Intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    crying continuous
    Item
    In case of intensity 3: was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
    boolean
    C0438697 (UMLS CUI [1])
    crying unaltered
    Item
    In case of intensity 3: was the crying unaltered for > 3 hours ?
    boolean
    C0438697 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Item
    Irritability/Fussiness on Day 0
    integer
    C0022107 (UMLS CUI [1])
    Pain
    Code List
    Irritability/Fussiness on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Irritability/Fussiness on Day 1
    integer
    C0022107 (UMLS CUI [1])
    Pain
    Code List
    Irritability/Fussiness on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Irritability/Fussiness on Day 2
    integer
    C0022107 (UMLS CUI [1])
    Pain
    Code List
    Irritability/Fussiness on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Irritability/Fussiness on Day 3
    integer
    C0022107 (UMLS CUI [1])
    Pain
    Code List
    Irritability/Fussiness on Day 3
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Irritability/Fussiness ongoing after day 3
    Item
    Irritability/Fussiness ongoing after day 3?
    boolean
    C0022107 (UMLS CUI [1])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0022107 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Causality
    Item
    Causality
    boolean
    C0015127 (UMLS CUI [1])
    C0022107 (UMLS CUI [2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0022107 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0022107 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Drowsiness
    Item
    Drowsiness
    boolean
    C0013144 (UMLS CUI [1])
    Item
    Drowsiness, Intensity
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Pain
    Code List
    Drowsiness, Intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Drowsiness on Day 0
    integer
    C0013144 (UMLS CUI [1])
    Pain
    Code List
    Drowsiness on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Drowsiness on Day 1
    integer
    C0013144 (UMLS CUI [1])
    Pain
    Code List
    Drowsiness on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Drowsiness on Day 2
    integer
    C0013144 (UMLS CUI [1])
    Pain
    Code List
    Drowsiness on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Drowsiness on Day 3
    integer
    C0013144 (UMLS CUI [1])
    Pain
    Code List
    Drowsiness on Day 3
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Drowsiness ongoing after day 3
    Item
    Drowsiness ongoing after day 3?
    boolean
    C0013144 (UMLS CUI [1])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0013144 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Causality
    Item
    Causality?
    boolean
    C0015127 (UMLS CUI [1])
    C0013144 (UMLS CUI [2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0013144 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0013144 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Loss of appetite
    Item
    Loss of appetite
    boolean
    C1971624 (UMLS CUI [1])
    Item
    Loss of appetite, Intensity
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Pain
    Code List
    Loss of appetite, Intensity
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite on Day 0
    integer
    C1971624 (UMLS CUI [1])
    Pain
    Code List
    Loss of appetite on Day 0
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite on Day 1
    integer
    C1971624 (UMLS CUI [1])
    Pain
    Code List
    Loss of appetite on Day 1
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite on Day 2
    integer
    C1971624 (UMLS CUI [1])
    Pain
    Code List
    Loss of appetite on Day 2
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Loss of appetite on Day 3
    integer
    C1971624 (UMLS CUI [1])
    Pain
    Code List
    Loss of appetite on Day 3
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Loss of appetite ongoing after day 3
    Item
    Loss of appetite ongoing after day 3?
    boolean
    C1971624 (UMLS CUI [1])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C1971624 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Causality
    Item
    Causality?
    boolean
    C0015127 (UMLS CUI [1])
    C1971624 (UMLS CUI [2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1971624 (UMLS CUI [2])
    Item
    Medically attended visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C1971624 (UMLS CUI [2])
    Medical advice Type
    Code List
    Medically attended visit Type
    CL Item
    Hospitalization (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial