ID

36053

Descripción

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

Palabras clave

Versiones (1)
  1. 11/4/19 11/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Long-Term Follow Up (Year 13; Study Conclusion) - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Center
Descripción

Center

Tipo de datos

text

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

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?
Descripción

If No, please specify the most appropriate reason

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

If Adverse Event or Serious Adverse Event, please specify

Tipo de datos

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
Descripción

If other, please specify

Tipo de datos

text

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

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Descripción

Investigator Signature Date

Tipo de datos

date

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

Investigator name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject experience any Serious Adverse Event during the study period?
Descripción

If Yes, specify total number of SAE's

Tipo de datos

boolean

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

Total number of SAE's

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Did the subject become pregnant during the study period?
Descripción

If Yes, complete the Pregnancy notification form.

Tipo de datos

text

Alias
UMLS CUI [1]
C3828490
Was the subject withdrawn from the study?
Descripción

If Yes, record major reason for withdrawal

Tipo de datos

boolean

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

Tick one box only

Tipo de datos

text

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

Please complete and submit SAE report

Tipo de datos

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.
Descripción

Please complete Non-serious Adverse Event section

Tipo de datos

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
Descripción

If protocol violation, please specify

Tipo de datos

text

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

If other reason, please specify

Tipo de datos

text

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

Who made the decision?

Tipo de datos

text

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

Date of last contact

Tipo de datos

date

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

If No, please give details in Adverse Events section.

Tipo de datos

boolean

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

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
Descripción

Previous Subject Number

Tipo de datos

integer

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

Date of birth

Tipo de datos

date

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

Please document reason for non participation

Tipo de datos

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
Descripción

Subject not eligible - Please specify criteria that are not fulfilled

Tipo de datos

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
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1519255
If reason is adverse events or serious adverse ebents, please specify.
Descripción

If reason is adverse events or serious adverse ebents, please specify.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
If other Reason for Subject not willing to participate, please specify
Descripción

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

Tipo de datos

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
Descripción

Date of contact

Tipo de datos

date

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

Diary Card - Local Symptoms

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

Local Symptoms

Tipo de datos

integer

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

Redness/ Swelling - Size in mm (Day 0)

Tipo de datos

integer

Unidades de medida
  • 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)
Descripción

Pain intensity (Day 0)

Tipo de datos

integer

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

Redness/ Swelling - Size in mm (Day 1)

Tipo de datos

integer

Unidades de medida
  • 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)
Descripción

Pain intensity (Day 1)

Tipo de datos

integer

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

Redness/ Swelling - Size in mm (Day 2)

Tipo de datos

integer

Unidades de medida
  • 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)
Descripción

Pain intensity (Day 2)

Tipo de datos

integer

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

Redness/ Swelling - Size in mm (Day 3)

Tipo de datos

integer

Unidades de medida
  • 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)
Descripción

Pain intensity (Day 3)

Tipo de datos

integer

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

Ongoing after Day 3?

Tipo de datos

boolean

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

Date of last day of symptom

Tipo de datos

date

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

Diary Card - Other local symptoms

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

Please specify side(s) and site(s)

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Intensity
Descripción

Intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518690
Symptoms start date
Descripción

Symptoms start date

Tipo de datos

date

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

Or check box if continuing

Tipo de datos

date

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

Check box if symptoms are continuing

Tipo de datos

integer

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

Diary Card - Medication

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

Trade/ Generic Name

Tipo de datos

text

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

Reason for medication

Tipo de datos

text

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

Total Daily Dose

Tipo de datos

text

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

Medication Start Date

Tipo de datos

date

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

Medication End date or check box if continuing

Tipo de datos

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
Descripción

Check box if medication continuing

Tipo de datos

integer

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

Diary Card - General Symptoms

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

General Symptom

Tipo de datos

integer

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

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.

Tipo de datos

integer

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

Record Temperature on Day 0, Day1, Day2, Day3

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0886414
°C
Fatigue intensity
Descripción

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

Tipo de datos

integer

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

Headache intensity on Day0, Day1, Day2, Day3

Tipo de datos

integer

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

Gastrointestinal symptoms intensity on Day0, Day1, Day2, Day3

Tipo de datos

integer

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

Symptoms ongoing after Day 3?

Tipo de datos

boolean

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

Date of last Day of Symptoms

Tipo de datos

date

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

Diary Card - Other general Symptoms

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

Description - please give details below

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Symptom intensity
Descripción

Symptom intensity

Tipo de datos

text

Alias
UMLS CUI [1]
C0518690
Symptom Start date
Descripción

Symptom Start date

Tipo de datos

date

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

Symptoms End date or check box if continuing

Tipo de datos

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
Descripción

Check box if symptoms continuing

Tipo de datos

integer

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

Long-Term Follow Up (Year 13; Study Conclusion) - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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?
Item
Did the subject experience any Serious Adverse Event during the study period?
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 during the study period?
text
C3828490 (UMLS CUI [1])
Did the subject become pregnant before the end of the study?
Code List
Did the subject become pregnant during the study period?
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
Subject (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])
Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
integer
C3846156 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Code List
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
CL Item
adverse events, or serious adverse event - please specify (1)
CL Item
other - please specify (2)
If reason is adverse events or serious adverse ebents, please specify.
Item
If reason is adverse events or serious adverse ebents, 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 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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