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ID

35958

Description

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 (2)
  1. 4/4/19 4/4/19 -
  2. 4/6/19 4/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

    English

    Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Center
    Description

    Center

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Follow-Up Studies
    Description

    Follow-Up Studies

    Alias
    UMLS CUI-1
    C0016441
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    Description

    If No, please specify the most appropriate reason

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0600109
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    Description

    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0392360
    If Adverse Event or Serious Adverse Event, please specify
    Description

    If Adverse Event or Serious Adverse Event, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C2348235
    If other, please specify
    Description

    If other, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Investigator signature
    Description

    Investigator signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator Signature
    Description

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator name
    Description

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    Description

    If Yes, specify total number of SAE's

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C2347804
    UMLS CUI [3]
    C2348563
    Total number of SAE's
    Description

    Total number of SAE's

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Did the subject become pregnant before the end of the study?
    Description

    If Yes, complete the Pregnancy notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961
    Was the subject withdrawn from the study?
    Description

    If Yes, record major reason for withdrawal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Major reason for withdrawal
    Description

    Tick one box only

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    If Serious adverse event, please specify SAE No
    Description

    Please complete and submit SAE report

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    If Non-serious adverse event, please specify AE No or solicited AE code.
    Description

    Please complete Non-serious Adverse Event section

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0805701
    If protocol violation, please specify
    Description

    If protocol violation, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C2348235
    If other reason, please specify
    Description

    If other reason, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C2348235
    Who made the decision?
    Description

    Who made the decision?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679006
    Date of last contact
    Description

    Date of last contact

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject in good condition at date of last contact?
    Description

    If No, please give details in Adverse Events section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Tracking Document - Reason for non participation
    Description

    Tracking Document - Reason for non participation

    Alias
    UMLS CUI-1
    C3889409
    UMLS CUI-3
    C0558080
    UMLS CUI-4
    C0679823
    UMLS CUI-5
    C0392360
    Previous Subject Number
    Description

    Previous Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C2242969
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Please document reason for non participation
    Description

    Please document reason for non participation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Subject not eligible - Please specify criteria that are not fulfilled
    Description

    Subject not eligible - Please specify criteria that are not fulfilled

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1555471
    UMLS CUI [1,2]
    C3828770
    UMLS CUI [1,3]
    C2348235
    Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
    Description

    Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3846156
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C1519255
    If other Reason for Subject not willing to participate, please specify
    Description

    If other Reason for Subject not willing to participate, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C1136454
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Date of contact
    Description

    Date of contact

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705415
    Diary Card - Local Symptoms
    Description

    Diary Card - Local Symptoms

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    Local Symptoms
    Description

    Local Symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [2]
    C2700396
    Redness/ Swelling - Size in mm (Day 0)
    Description

    Redness/ Swelling - Size in mm (Day 0)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2,1]
    C0038999
    UMLS CUI [2,2]
    C0456389
    mm
    Pain intensity (Day 0)
    Description

    Pain intensity (Day 0)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Redness/ Swelling - Size in mm (Day 1)
    Description

    Redness/ Swelling - Size in mm (Day 1)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2,1]
    C0038999
    UMLS CUI [2,2]
    C0456389
    mm
    Pain intensity (Day 1)
    Description

    Pain intensity (Day 1)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Redness/ Swelling - Size in mm (Day 2)
    Description

    Redness/ Swelling - Size in mm (Day 2)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2,1]
    C0038999
    UMLS CUI [2,2]
    C0456389
    mm
    Pain intensity (Day 2)
    Description

    Pain intensity (Day 2)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Redness/ Swelling - Size in mm (Day 3)
    Description

    Redness/ Swelling - Size in mm (Day 3)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2,1]
    C0038999
    UMLS CUI [2,2]
    C0456389
    mm
    Pain intensity (Day 3)
    Description

    Pain intensity (Day 3)

    Data type

    integer

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

    Ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptom
    Description

    Date of last day of symptom

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C1457887
    Diary Card - Other local symptoms
    Description

    Diary Card - Other local symptoms

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    UMLS CUI-4
    C0205394
    Description
    Description

    Please specify side(s) and site(s)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    Intensity
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Symptoms start date
    Description

    Symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0808070
    Symptoms end date
    Description

    Or check box if continuing

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0806020
    Check box if symptoms are continuing
    Description

    Check box if symptoms are continuing

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    Diary Card - Medication
    Description

    Diary Card - Medication

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0013227
    Trade/ Generic Name
    Description

    Trade/ Generic Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    UMLS CUI [2]
    C0592502
    Reason for medication
    Description

    Reason for medication

    Data type

    text

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

    Total Daily Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0439810
    Medication Start Date
    Description

    Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Medication End date or check box if continuing
    Description

    Medication End date or check box if continuing

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0549178
    Check box if medication continuing
    Description

    Check box if medication continuing

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Diary Card - General Symptoms
    Description

    Diary Card - General Symptoms

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0159028
    General Symptom
    Description

    General Symptom

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0159028
    If Temperature, record route of measurement
    Description

    Please record the temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0449444
    Temperature
    Description

    Record Temperature on Day 0, Day1, Day2, Day3

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0886414
    °C
    Fatigue intensity
    Description

    Record Intensity of Fatigue on Day0, Day1, Day2, Day3

    Data type

    integer

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

    Headache intensity on Day0, Day1, Day2, Day3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C0518690
    Gastrointestinal symptoms intensity
    Description

    Gastrointestinal symptoms intensity on Day0, Day1, Day2, Day3

    Data type

    integer

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

    Symptoms ongoing after Day 3?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    Date of last Day of Symptoms
    Description

    Date of last Day of Symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C2700396
    Diary Card - Other general Symptoms
    Description

    Diary Card - Other general Symptoms

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0029625
    Description - please give details below
    Description

    Description - please give details below

    Data type

    text

    Alias
    UMLS CUI [1]
    C0678257
    Symptom intensity
    Description

    Symptom intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518690
    Symptom Start date
    Description

    Symptom Start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0808070
    Symptoms End date or check box if continuing
    Description

    Symptoms End date or check box if continuing

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C1457887
    UMLS CUI [2,2]
    C0549178
    Check box if symptoms continuing
    Description

    Check box if symptoms continuing

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
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    Similar models

    Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Center
    Item
    Center
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Follow-Up Studies
    C0016441 (UMLS CUI-1)
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    Item
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    boolean
    C0016441 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    Item
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    integer
    C0016441 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    If subject would not be willing to participate in a follow-up study, please specify the reason
    Code List
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    CL Item
    Adverse Events, or Serious Adverse Events (1)
    CL Item
    Other (2)
    If Adverse Event or Serious Adverse Event, please specify
    Item
    If Adverse Event or Serious Adverse Event, please specify
    text
    C0877248 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    If other, please specify
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Investigator signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator name
    Item
    Investigator name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    Item
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    boolean
    C1519255 (UMLS CUI [1])
    C2347804 (UMLS CUI [2])
    C2348563 (UMLS CUI [3])
    Total number of SAE's
    Item
    Total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant before the end of the study?
    text
    C0032961 (UMLS CUI [1])
    Did the subject become pregnant before the end of the study?
    Code List
    Did the subject become pregnant before the end of the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Not Applicable (not of childbearing potential or male) (N/A)
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Major reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Major reason for withdrawal
    Code List
    Major reason for withdrawal
    CL Item
    Serious adverse event  (SAE)
    CL Item
    Non-Serious adverse event  (AEX)
    CL Item
    Protocol violation, please specify (PTV)
    CL Item
    Consent withdrawal, not due to an adverse event.  (CWS)
    CL Item
    Migrated / moved from the study area  (MIG)
    CL Item
    Lost to follow-up.  (LFU)
    CL Item
    Other, please specify (OTH)
    If Serious adverse event, please specify SAE No
    Item
    If Serious adverse event, please specify SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    If Non-serious adverse event, please specify AE No or solicited AE code.
    Item
    If Non-serious adverse event, please specify AE No or solicited AE code.
    text
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0805701 (UMLS CUI [2,2])
    If protocol violation, please specify
    Item
    If protocol violation, please specify
    text
    C1709750 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    If other reason, please specify
    Item
    If other reason, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Who made the decision?
    text
    C0679006 (UMLS CUI [1])
    Who made the decision?
    Code List
    Who made the decision?
    CL Item
    Investigator (I)
    CL Item
    Parents/ Guardians (P)
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Was the subject in good condition at date of last contact?
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Item Group
    Tracking Document - Reason for non participation
    C3889409 (UMLS CUI-1)
    C0558080 (UMLS CUI-3)
    C0679823 (UMLS CUI-4)
    C0392360 (UMLS CUI-5)
    Previous Subject Number
    Item
    Previous Subject Number
    integer
    C2348585 (UMLS CUI [1,1])
    C2242969 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Please document reason for non participation
    integer
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    Code List
    Please document reason for non participation
    CL Item
    Subject not eligible - please specify criteria that are not fulfilled (1)
    CL Item
    Subject lost to follow-up or not reached (2)
    CL Item
    Subject eligible but not willing to participate due to adverse events, or serious adverse event or other (3)
    CL Item
    Subject died (4)
    Subject not eligible - Please specify criteria that are not fulfilled
    Item
    Subject not eligible - Please specify criteria that are not fulfilled
    text
    C1555471 (UMLS CUI [1,1])
    C3828770 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
    Item
    Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
    text
    C3846156 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    If other Reason for Subject not willing to participate, please specify
    Item
    If other Reason for Subject not willing to participate, please specify
    text
    C0392360 (UMLS CUI [1,1])
    C1136454 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Date of contact
    Item
    Date of contact
    date
    C0011008 (UMLS CUI [1,1])
    C1705415 (UMLS CUI [1,2])
    Item Group
    Diary Card - Local Symptoms
    C3890583 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Item
    Local Symptoms
    integer
    C1457887 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [2])
    Local Symptoms
    Code List
    Local Symptoms
    CL Item
    Redness  (1)
    CL Item
    Swelling  (2)
    CL Item
    Pain (3)
    Redness/ Swelling - Size in mm (Day 0)
    Item
    Redness/ Swelling - Size in mm (Day 0)
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    Item
    Pain intensity (Day 0)
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity (Day 0)
    Code List
    Pain intensity (Day 0)
    CL Item
    Absent  (0)
    CL Item
    Painful on touch (1)
    CL Item
    Painful when limb is moved (2)
    CL Item
    Pain that prevents normal activity (3)
    Redness/ Swelling - Size in mm (Day 1)
    Item
    Redness/ Swelling - Size in mm (Day 1)
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    Item
    Pain intensity (Day 1)
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity (Day 1)
    Code List
    Pain intensity (Day 1)
    CL Item
    Absent  (0)
    CL Item
    Painful on touch  (1)
    CL Item
    Painful when limb is moved  (2)
    CL Item
    Pain that prevents normal activity (3)
    Redness/ Swelling - Size in mm (Day 2)
    Item
    Redness/ Swelling - Size in mm (Day 2)
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    Item
    Pain intensity (Day 2)
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity (Day 2)
    Code List
    Pain intensity (Day 2)
    CL Item
    Absent  (0)
    CL Item
    Painful on touch  (1)
    CL Item
    Painful when limb is moved  (2)
    CL Item
    Pain that prevents normal activity (3)
    Redness/ Swelling - Size in mm (Day 3)
    Item
    Redness/ Swelling - Size in mm (Day 3)
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    Item
    Pain intensity (Day 3)
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity (Day 3)
    Code List
    Pain intensity (Day 3)
    CL Item
    Absent  (0)
    CL Item
    Painful on touch  (1)
    CL Item
    Painful when limb is moved  (2)
    CL Item
    Pain that prevents normal activity (3)
    Ongoing after Day 3?
    Item
    Ongoing after Day 3?
    boolean
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptom
    Item
    Date of last day of symptom
    date
    C0011008 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item Group
    Diary Card - Other local symptoms
    C3890583 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Description
    Item
    Description
    text
    C0678257 (UMLS CUI [1])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1])
    Intensity
    Code List
    Intensity
    CL Item
    Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities.  (1)
    CL Item
    Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities.  (2)
    CL Item
    Severe: An adverse event which prevents normal, everyday activities.(In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
    Symptoms start date
    Item
    Symptoms start date
    date
    C1457887 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Symptoms end date
    Item
    Symptoms end date
    date
    C1457887 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Check box if symptoms are continuing
    integer
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Check box if symptoms are continuing
    Code List
    Check box if symptoms are continuing
    CL Item
    Symptoms continuing (1)
    Item Group
    Diary Card - Medication
    C3890583 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    Trade/ Generic Name
    Item
    Trade/ Generic Name
    text
    C2360065 (UMLS CUI [1])
    C0592502 (UMLS CUI [2])
    Reason for medication
    Item
    Reason for medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Medication Start Date
    Item
    Medication Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication End date or check box if continuing
    Item
    Medication End date or check box if continuing
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C0549178 (UMLS CUI [2,2])
    Item
    Check box if medication continuing
    integer
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Check box if medication continuing
    Code List
    Check box if medication continuing
    CL Item
    Medication continuing (1)
    Item Group
    Diary Card - General Symptoms
    C3890583 (UMLS CUI-1)
    C0159028 (UMLS CUI-2)
    Item
    General Symptom
    integer
    C0159028 (UMLS CUI [1])
    General Symptom
    Code List
    General Symptom
    CL Item
    Temperature (1)
    CL Item
    Fatigue (2)
    CL Item
    Headache (3)
    CL Item
    Gastrointestinal symptoms (4)
    Item
    If Temperature, record route of measurement
    integer
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    If Temperature, record route of measurement
    Code List
    If Temperature, record route of measurement
    CL Item
    Axillary (1)
    CL Item
    Oral (2)
    CL Item
    Rectal (3)
    Temperature
    Item
    Temperature
    float
    C0886414 (UMLS CUI [1])
    Item
    Fatigue intensity
    integer
    C0015672 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Fatigue intensity
    Code List
    Fatigue intensity
    CL Item
    Normal  (0)
    CL Item
    Fatigue that is easily tolerated  (1)
    CL Item
    Fatigue that interferes with normal activity  (2)
    CL Item
    Fatigue that prevents normal activity (3)
    Item
    Headache intensity
    integer
    C0018681 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Headache intensity
    Code List
    Headache intensity
    CL Item
    Normal  (0)
    CL Item
    Headache that is easily tolerated  (1)
    CL Item
    Headache that interferes with normal activity  (2)
    CL Item
    Headache that prevents normal activity (3)
    Item
    Gastrointestinal symptoms intensity
    integer
    C0426576 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Gastrointestinal symptoms intensity
    Code List
    Gastrointestinal symptoms intensity
    CL Item
    Normal  (0)
    CL Item
    Gastrointestinal symptoms that are easily tolerated  (1)
    CL Item
    Gastrointestinal symptoms that interfere with normal activity  (2)
    CL Item
    Gastrointestinal symptoms that prevent normal activity (3)
    Symptoms ongoing after Day 3?
    Item
    Symptoms ongoing after Day 3?
    boolean
    C1457887 (UMLS CUI [1,1])
    C0549178 (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])
    Item Group
    Diary Card - Other general Symptoms
    C3890583 (UMLS CUI-1)
    C0029625 (UMLS CUI-2)
    Description - please give details below
    Item
    Description - please give details below
    text
    C0678257 (UMLS CUI [1])
    Symptom intensity
    Item
    Symptom intensity
    text
    C0518690 (UMLS CUI [1])
    Symptom Start date
    Item
    Symptom Start date
    date
    C1457887 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Symptoms End date or check box if continuing
    Item
    Symptoms End date or check box if continuing
    date
    C1457887 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [2,1])
    C0549178 (UMLS CUI [2,2])
    Item
    Check box if symptoms continuing
    integer
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Check box if symptoms continuing
    Code List
    Check box if symptoms continuing
    CL Item
    Symptoms continuing (1)
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