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ID

44193

Description

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (5)
  1. 08/04/2019 08/04/2019 -
  2. 08/04/2019 08/04/2019 -
  3. 08/04/2019 08/04/2019 -
  4. 11/04/2019 11/04/2019 -
  5. 20/09/2021 20/09/2021 -
Copyright Holder

GlaxoSmithKline

Uploaded on

20 de setembro de 2021

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Creative Commons BY-NC 3.0
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    Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

    English

    Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

    1 forms  
    Administration
    Description

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Informed Consent date:
    Description

    I certify that Informed Consent has been obtained prior to any study procedure.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Centre number
    Description

    Centre number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    Race

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034510
    If other race, please specify
    Description

    If other race, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    General Medical History / Physical Examination
    Description

    General Medical History / Physical Examination

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

    Please tick appropriate box and give diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C2347804
    UMLS CUI [2,3]
    C0332152
    Medical Condition
    Description

    Medical Condition

    Alias
    UMLS CUI-1
    C0012634
    Medical Condition
    Description

    Medical Condition

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0012634
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Status
    Description

    Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449438
    Laboratory Tests
    Description

    Laboratory Tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    Description

    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0201473
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C0201478
    Date of Blood sample been taken
    Description

    Please complete only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    Description

    Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0170300
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1517741
    UMLS CUI [1,4]
    C1711239
    UMLS CUI [2,1]
    C2240392
    UMLS CUI [2,2]
    C0545082
    UMLS CUI [2,3]
    C1517741
    UMLS CUI [2,4]
    C1711239
    If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
    Description

    If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0170300
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C2240392
    UMLS CUI [2,2]
    C2348235
    Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    Description

    Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3652495
    UMLS CUI [1,2]
    C0019080
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [2,1]
    C0062525
    UMLS CUI [2,2]
    C0019080
    UMLS CUI [2,3]
    C0332152
    If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
    Description

    If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3652495
    UMLS CUI [1,2]
    C0019080
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0062525
    UMLS CUI [2,2]
    C0019080
    UMLS CUI [2,3]
    C0332152
    UMLS CUI [2,4]
    C2348235
    Has an additional blood sample been taken prior to additional vaccine dose?
    Description

    Has an additional blood sample been taken prior to additional vaccine dose?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1524062
    UMLS CUI [2,1]
    C0042210
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C1524062
    Additional blood sample Date
    Description

    Please complete only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1524062
    UMLS CUI [1,3]
    C0011008
    HCG Urine Pregnancy Test
    Description

    HCG Urine Pregnancy Test

    Alias
    UMLS CUI-1
    C0430056
    Has a urine sample been taken ?
    Description

    Has a urine sample been taken ?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0430056
    Date of urine sample been taken
    Description

    Date if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C0011008
    Result
    Description

    Result

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1274040
    Blood Sample Conclusion
    Description

    Blood Sample Conclusion

    Alias
    UMLS CUI-1
    C0178913
    UMLS CUI-2
    C1254595
    Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
    Description

    If yes, please give an additional vaccine dose of Twinrix™ Adult (720/20)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521144
    UMLS CUI [1,2]
    C0062524
    UMLS CUI [2]
    C0475208
    Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
    Description

    If yes, please give an additional vaccine dose of either Engerix™ (20 µg) vaccine or Havrix™ (720 EL.U) vaccine

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0521144
    UMLS CUI [1,2]
    C0201478
    UMLS CUI [2]
    C0475208
    Vaccine Administration
    Description

    Vaccine Administration

    Alias
    UMLS CUI-1
    C2368628
    Date
    Description

    fill in only if different from visit date

    Data type

    date

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

    Pre-Vaccination temperature

    Data type

    float

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

    Temperature Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0449687
    Vaccine Administration
    Description

    Vaccine Administration

    Alias
    UMLS CUI-1
    C2368628
    Vaccine Administration
    Description

    (only one box must be ticked by vaccine)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2368628
    Replacement vial
    Description

    Replacement vial

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    UMLS CUI [1,3]
    C0600091
    Wrong vial number
    Description

    Wrong vial number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0184301
    Side/ Site Route
    Description

    Side/ Site Route

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0441987
    Has the study vaccine been administered according to the Protocol?
    Description

    Has the study vaccine been administered according to the Protocol?

    Data type

    boolean

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

    If study vaccine has not been administered according to the Protocol, please tick all items that apply

    Data type

    integer

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

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Why not administered?
    Description

    Please tick the ONE most appropriate category for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    If not administered because of SAE, please specify SAE No.
    Description

    If not administered because of SAE, please specify SAE No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C0237753
    If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
    Description

    If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0237753
    If other reason for non administration, please specify
    Description

    (e.g. consent withdrawal, protocol violation, …)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Please tick who took the decision
    Description

    Please tick who took the decision

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679006
    Unsolicited Adverse Events
    Description

    Unsolicited Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
    Description

    Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29)post-vaccination?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C0042196
    Solicited Adverse Events - Local Symptoms
    Description

    Solicited Adverse Events - Local Symptoms

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

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

    Data type

    text

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

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0332575
    Redness size Day 0
    Description

    Redness size Day 0

    Data type

    integer

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

    Redness size Day 1

    Data type

    integer

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

    Redness size Day 2

    Data type

    integer

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

    Redness size Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0332575
    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]
    C3174772
    If Redness is ongoing, record date of last Day of Symptoms
    Description

    If Redness is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0332575
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Swelling
    Description

    Swelling

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038999
    Swelling Size Day 0
    Description

    Swelling Size Day 0

    Data type

    integer

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

    Swelling Size Day 1

    Data type

    integer

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

    Swelling Size Day 2

    Data type

    integer

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

    Swelling Size Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    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]
    C3174772
    If Swelling is ongoing, record date of last Day of Symptoms
    Description

    If Swelling is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0038999
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Pain
    Description

    Pain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030193
    Pain intensity Day 0
    Description

    Pain intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 1
    Description

    Pain intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 2
    Description

    Pain intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 3
    Description

    Pain intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain Ongoing after Day 3?
    Description

    Pain Ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C3174772
    If Pain is ongoing, record date of last Day of Symptoms
    Description

    If Pain is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0030193
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Solicited Adverse Events - General Symptoms
    Description

    Solicited Adverse Events - General Symptoms

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

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C0037088
    Fever
    Description

    Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Temperature Route
    Description

    Temperature Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0449687
    Temperature Day 0
    Description

    Temperature Day 0

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature not taken Day 0
    Description

    Temperature not taken Day 0

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0437722
    Temperature Day 1
    Description

    Temperature Day 1

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature not taken Day 1
    Description

    Temperature not taken Day 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0437722
    Temperature Day 2
    Description

    Temperature Day 2

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature not taken Day 2
    Description

    Temperature not taken Day 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0437722
    Temperature Day 3
    Description

    Temperature Day 3

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature not taken Day 3
    Description

    Temperature not taken Day 3

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0437722
    Fever ongoing after Day 3?
    Description

    Fever ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C3174772
    If Fever is ongoing, record date of last Day of Symptoms
    Description

    If Fever is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0015967
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Fever - Causality?
    Description

    Fever - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0085978
    Fatigue
    Description

    Fatigue

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015672
    Fatigue intensity Day 0
    Description

    Fatigue intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0518690
    Fatigue intensity Day 1
    Description

    Fatigue intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0518690
    Fatigue intensity Day 2
    Description

    Fatigue intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0518690
    Fatigue intensity Day 3
    Description

    Fatigue intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0518690
    Fatigue ongoing after Day 3?
    Description

    Fatigue ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C3174772
    If Fatigue is ongoing, record date of last Day of Symptoms
    Description

    If Fatigue is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0015672
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Fatigue - Causality?
    Description

    Fatigue - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0085978
    Headache
    Description

    Headache

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018681
    Headache intensity Day 0
    Description

    Headache intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0518690
    Headache intensity Day 1
    Description

    Headache intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0518690
    Headache intensity Day 2
    Description

    Headache intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0518690
    Headache intensity Day 3
    Description

    Headache intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0518690
    Headache ongoing after Day 3?
    Description

    Headache ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C3174772
    If Headache is ongoing, record date of last Day of Symptoms
    Description

    If Headache is ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0018681
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Headache - Causality?
    Description

    Headache - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0085978
    Gastrointestinal symptoms
    Description

    Gastrointestinal symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0426576
    Gastrointestinal symptoms intensity Day 0
    Description

    Gastrointestinal symptoms intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C0518690
    Gastrointestinal symptoms intensity Day 1
    Description

    Gastrointestinal symptoms intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C0518690
    Gastrointestinal symptoms intensity Day 2
    Description

    Gastrointestinal symptoms intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C0518690
    Gastrointestinal symptoms intensity Day 3
    Description

    Gastrointestinal symptoms intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C0518690
    Gastrointestinal Symptoms ongoing after Day 3?
    Description

    Gastrointestinal Symptoms ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C3174772
    If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
    Description

    If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0426576
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1457887
    Gastrointestinal Symptoms - Causality?
    Description

    Gastrointestinal Symptoms - Causality?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0426576
    UMLS CUI [1,2]
    C0085978
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    Similar models

    Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Informed Consent date
    Item
    Informed Consent date:
    date
    C2985782 (UMLS CUI [1])
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Centre number
    Item
    Centre number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Black (1)
    CL Item
    Arabic/North African (4)
    CL Item
    White/Caucasian (2)
    CL Item
    East & South East Asian (5)
    CL Item
    South Asian (6)
    CL Item
    American Hispanic (7)
    CL Item
    Japanese (8)
    CL Item
    Other, please specify (9)
    If other race, please specify
    Item
    If other race, please specify
    text
    C0034510 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    General Medical History / Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    Item
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    boolean
    C0521987 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C2347804 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [2,3])
    Item Group
    Medical Condition
    C0012634 (UMLS CUI-1)
    Item
    Medical Condition
    integer
    C0012634 (UMLS CUI [1])
    Diagnosis
    Code List
    Medical Condition
    CL Item
    Cutaneous (10)
    CL Item
    Eyes (5)
    CL Item
    Ears-Nose-Throat (6)
    CL Item
    Cardiovascular (2)
    CL Item
    Respiratory (3)
    CL Item
    Gastrointestinal (1)
    CL Item
    Muskuloskeletal (7)
    CL Item
    Neurological (8)
    CL Item
    Genitourinary (12)
    CL Item
    Haematology (11)
    CL Item
    Allergies (4)
    CL Item
    Endocrine (9)
    CL Item
    Other (specify) (99)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Status
    integer
    C0449438 (UMLS CUI [1])
    Status
    Code List
    Status
    CL Item
    Past (1)
    CL Item
    Current (2)
    Item Group
    Laboratory Tests
    C0022885 (UMLS CUI-1)
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    Item
    Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0201473 (UMLS CUI [1,2])
    C0005834 (UMLS CUI [2,1])
    C0201478 (UMLS CUI [2,2])
    Date of Blood sample been taken
    Item
    Date of Blood sample been taken
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    Item
    Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
    boolean
    C0170300 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    C1711239 (UMLS CUI [1,4])
    C2240392 (UMLS CUI [2,1])
    C0545082 (UMLS CUI [2,2])
    C1517741 (UMLS CUI [2,3])
    C1711239 (UMLS CUI [2,4])
    Item
    If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
    integer
    C0170300 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C2240392 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
    Code List
    If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
    CL Item
    Hepatitis A vaccine (1)
    CL Item
    Hepatitis B vaccine (2)
    CL Item
    Combined Hepatitis A and B vaccine (3)
    Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    Item
    Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
    boolean
    C3652495 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C0062525 (UMLS CUI [2,1])
    C0019080 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [2,3])
    Item
    If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
    integer
    C3652495 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0062525 (UMLS CUI [2,1])
    C0019080 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [2,3])
    C2348235 (UMLS CUI [2,4])
    If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
    Code List
    If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
    CL Item
    Hepatitis A immunoglobulins (1)
    CL Item
    Hepatitis B immunoglobulins (2)
    Has an additional blood sample been taken prior to additional vaccine dose?
    Item
    Has an additional blood sample been taken prior to additional vaccine dose?
    boolean
    C0005834 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C1524062 (UMLS CUI [2,3])
    Additional blood sample Date
    Item
    Additional blood sample Date
    date
    C0005834 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    HCG Urine Pregnancy Test
    C0430056 (UMLS CUI-1)
    Item
    Has a urine sample been taken ?
    integer
    C0430056 (UMLS CUI [1])
    Has a urine sample been taken ?
    Code List
    Has a urine sample been taken ?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (not of childbearing potential or male) (3)
    Date of urine sample been taken
    Item
    Date of urine sample been taken
    date
    C0430056 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result
    integer
    C1274040 (UMLS CUI [1])
    Result
    Code List
    Result
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    Blood Sample Conclusion
    C0178913 (UMLS CUI-1)
    C1254595 (UMLS CUI-2)
    Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
    Item
    Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
    boolean
    C0521144 (UMLS CUI [1,1])
    C0062524 (UMLS CUI [1,2])
    C0475208 (UMLS CUI [2])
    Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
    Item
    Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
    text
    C0521144 (UMLS CUI [1,1])
    C0201478 (UMLS CUI [1,2])
    C0475208 (UMLS CUI [2])
    Item Group
    Vaccine Administration
    C2368628 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Pre-Vaccination temperature
    Item
    Pre-Vaccination temperature
    float
    C0005903 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Item
    Temperature Route
    text
    C0005903 (UMLS CUI [1,1])
    C0449687 (UMLS CUI [1,2])
    Temperature Route
    Code List
    Temperature Route
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    Item Group
    Vaccine Administration
    C2368628 (UMLS CUI-1)
    Item
    Vaccine Administration
    integer
    C2368628 (UMLS CUI [1])
    Vaccine Administration
    Code List
    Vaccine Administration
    CL Item
    Twinrix™ Adult (720/20) Vaccine  (1)
    CL Item
    Twinrix™ Adult (720/20) Vaccine - Replacement vial (2)
    CL Item
    Twinrix™ Adult (720/20) Vaccine - Wrong vial number (3)
    CL Item
    Twinrix™ Adult (720/20) Vaccine not administered (4)
    CL Item
    Engerix™ (20 µg) Vaccine  (5)
    CL Item
    Engerix™ (20 µg) Vaccine - Replacement vial (6)
    CL Item
    Engerix™ (20 µg) Vaccine - Wrong vial number (7)
    CL Item
    Engerix™ (20 µg) Vaccine not administered (8)
    CL Item
    Havrix™ (720 EL.U) Vaccine  (9)
    CL Item
    Havrix™ (720 EL.U) Vaccine - Replacement vial (10)
    CL Item
    Havrix™ (720 EL.U) Vaccine - Wrong vial number (11)
    CL Item
    Havrix™ (720 EL.U)Vaccine not administered (12)
    Item
    Replacement vial
    integer
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Vaccine Administration
    Code List
    Replacement vial
    Wrong vial number
    Item
    Wrong vial number
    integer
    C0184301 (UMLS CUI [1])
    Item
    Side/ Site Route
    integer
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [1,4])
    Side/ Site Route
    Code List
    Side/ Site Route
    CL Item
    Non dominant Deltoid i.m. (1)
    Has the study vaccine been administered according to the Protocol?
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Item
    If study vaccine has not been administered according to the Protocol, please tick all items that apply
    integer
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    If study vaccine has not been administered according to the Protocol, please tick all items that apply
    Code List
    If study vaccine has not been administered according to the Protocol, please tick all items that apply
    CL Item
    Dominant (1)
    CL Item
    Non dominant (2)
    CL Item
    Deltoid (3)
    CL Item
    Thigh (4)
    CL Item
    Buttock (5)
    CL Item
    i.m. (6)
    CL Item
    s.c. (7)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item
    Why not administered?
    text
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Why not administered?
    Code List
    Why not administered?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form)  (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section)  (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation, …) (OTH)
    If not administered because of SAE, please specify SAE No.
    Item
    If not administered because of SAE, please specify SAE No.
    integer
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
    Item
    If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
    integer
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    C1518404 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    If other reason for non administration, please specify
    Item
    If other reason for non administration, please specify
    text
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Please tick who took the decision
    text
    C0679006 (UMLS CUI [1])
    Please tick who took the decision
    Code List
    Please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents/ Guardians (P)
    Item Group
    Unsolicited Adverse Events
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
    text
    C1519255 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C0877248 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
    CL Item
    Information not available  (U)
    CL Item
    No Vaccine administered  (NA)
    CL Item
    No (N)
    CL Item
    Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (Y)
    Item Group
    Solicited Adverse Events - Local Symptoms
    C0877248 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    text
    C0037088 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Code List
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    CL Item
    Information not available  (U)
    CL Item
    No Vaccine administered  (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
    Redness
    Item
    Redness
    boolean
    C0332575 (UMLS CUI [1])
    Redness size Day 0
    Item
    Redness size Day 0
    integer
    C0456389 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    Redness size Day 1
    Item
    Redness size Day 1
    integer
    C0456389 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    Redness size Day 2
    Item
    Redness size Day 2
    integer
    C0456389 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    Redness size Day 3
    Item
    Redness size Day 3
    integer
    C0456389 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    Redness Ongoing after Day 3?
    Item
    Redness Ongoing after Day 3?
    boolean
    C0332575 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Redness is ongoing, record date of last Day of Symptoms
    Item
    If Redness is ongoing, record date of last Day of Symptoms
    date
    C0332575 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Swelling
    Item
    Swelling
    boolean
    C0038999 (UMLS CUI [1])
    Swelling Size Day 0
    Item
    Swelling Size Day 0
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling Size Day 1
    Item
    Swelling Size Day 1
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling Size Day 2
    Item
    Swelling Size Day 2
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling Size Day 3
    Item
    Swelling Size Day 3
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling Ongoing after Day 3?
    Item
    Swelling Ongoing after Day 3? +
    boolean
    C0038999 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Swelling is ongoing, record date of last Day of Symptoms
    Item
    If Swelling is ongoing, record date of last Day of Symptoms
    date
    C0038999 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Pain
    Item
    Pain
    boolean
    C0030193 (UMLS CUI [1])
    Item
    Pain intensity Day 0
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 0
    Code List
    Pain intensity Day 0
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Pain intensity Day 1
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 1
    Code List
    Pain intensity Day 1
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Pain intensity Day 2
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 2
    Code List
    Pain intensity Day 2
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Pain intensity Day 3
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 3
    Code List
    Pain intensity Day 3
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Pain Ongoing after Day 3?
    Item
    Pain Ongoing after Day 3?
    boolean
    C0030193 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Pain is ongoing, record date of last Day of Symptoms
    Item
    If Pain is ongoing, record date of last Day of Symptoms
    date
    C0030193 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Item Group
    Solicited Adverse Events - General Symptoms
    C0877248 (UMLS CUI-1)
    C0159028 (UMLS CUI-2)
    Item
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    text
    C0037088 (UMLS CUI [1])
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    Code List
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    CL Item
    Information not available  (U)
    CL Item
    No Vaccine administered  (NA)
    CL Item
    No  (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Item
    Temperature Route
    text
    C0005903 (UMLS CUI [1,1])
    C0449687 (UMLS CUI [1,2])
    Temperature Route
    Code List
    Temperature Route
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    Temperature Day 0
    Item
    Temperature Day 0
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature not taken Day 0
    integer
    C0437722 (UMLS CUI [1])
    Temperature not taken
    Code List
    Temperature not taken Day 0
    CL Item
    Not taken (1)
    Temperature Day 1
    Item
    Temperature Day 1
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature not taken Day 1
    integer
    C0437722 (UMLS CUI [1])
    Temperature not taken Day 1
    Code List
    Temperature not taken Day 1
    CL Item
    Not taken (1)
    Temperature Day 2
    Item
    Temperature Day 2
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature not taken Day 2
    integer
    C0437722 (UMLS CUI [1])
    Temperature not taken Day 2
    Code List
    Temperature not taken Day 2
    CL Item
    Not taken (1)
    Temperature Day 3
    Item
    Temperature Day 3
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature not taken Day 3
    integer
    C0437722 (UMLS CUI [1])
    Temperature not taken Day 3
    Code List
    Temperature not taken Day 3
    CL Item
    Not taken (1)
    Fever ongoing after Day 3?
    Item
    Fever ongoing after Day 3?
    boolean
    C0015967 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Fever is ongoing, record date of last Day of Symptoms
    Item
    If Fever is ongoing, record date of last Day of Symptoms
    date
    C0015967 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Fever - Causality?
    Item
    Fever - Causality?
    boolean
    C0015967 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    Fatigue
    Item
    Fatigue
    boolean
    C0015672 (UMLS CUI [1])
    Item
    Fatigue intensity Day 0
    integer
    C0015672 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Fatigue intensity Day 0
    Code List
    Fatigue intensity Day 0
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Fatigue intensity Day 1
    integer
    C0015672 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Fatigue intensity Day 1
    Code List
    Fatigue intensity Day 1
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Fatigue intensity Day 2
    integer
    C0015672 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Fatigue intensity Day 2
    Code List
    Fatigue intensity Day 2
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Fatigue intensity Day 3
    integer
    C0015672 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Fatigue intensity Day 3
    Code List
    Fatigue intensity Day 3
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Fatigue ongoing after Day 3?
    Item
    Fatigue ongoing after Day 3?
    boolean
    C0015672 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Fatigue is ongoing, record date of last Day of Symptoms
    Item
    If Fatigue is ongoing, record date of last Day of Symptoms
    date
    C0015672 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Fatigue - Causality?
    Item
    Fatigue - Causality?
    boolean
    C0015672 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    Headache
    Item
    Headache
    boolean
    C0018681 (UMLS CUI [1])
    Item
    Headache intensity Day 0
    integer
    C0018681 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Headache intensity Day 0
    Code List
    Headache intensity Day 0
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Headache intensity Day 1
    integer
    C0018681 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Headache intensity Day 1
    Code List
    Headache intensity Day 1
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Headache intensity Day 2
    integer
    C0018681 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Headache intensity Day 2
    Code List
    Headache intensity Day 2
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Headache intensity Day 3
    integer
    C0018681 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Headache intensity Day 3
    Code List
    Headache intensity Day 3
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Headache ongoing after Day 3?
    Item
    Headache ongoing after Day 3?
    boolean
    C0018681 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Headache is ongoing, record date of last Day of Symptoms
    Item
    If Headache is ongoing, record date of last Day of Symptoms
    date
    C0018681 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Headache - Causality?
    Item
    Headache - Causality?
    boolean
    C0018681 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    Gastrointestinal symptoms
    Item
    Gastrointestinal symptoms
    boolean
    C0426576 (UMLS CUI [1])
    Item
    Gastrointestinal symptoms intensity Day 0
    integer
    C0426576 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Gastrointestinal symptoms intensity Day 0
    Code List
    Gastrointestinal symptoms intensity Day 0
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Gastrointestinal symptoms intensity Day 1
    integer
    C0426576 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Gastrointestinal symptoms intensity Day 1
    Code List
    Gastrointestinal symptoms intensity Day 1
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Gastrointestinal symptoms intensity Day 2
    integer
    C0426576 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Gastrointestinal symptoms intensity Day 2
    Code List
    Gastrointestinal symptoms intensity Day 2
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Item
    Gastrointestinal symptoms intensity Day 3
    integer
    C0426576 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Gastrointestinal symptoms intensity Day 3
    Code List
    Gastrointestinal symptoms intensity Day 3
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    None (0)
    Gastrointestinal Symptoms ongoing after Day 3?
    Item
    Gastrointestinal Symptoms ongoing after Day 3?
    boolean
    C0426576 (UMLS CUI [1,1])
    C3174772 (UMLS CUI [1,2])
    If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
    Item
    If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
    date
    C0426576 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [2,3])
    Gastrointestinal Symptoms - Causality?
    Item
    Gastrointestinal Symptoms - Causality?
    boolean
    C0426576 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
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