ID

36044

Beschreibung

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

Stichworte

Versionen (1)
  1. 11.04.19 11.04.19 -
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GlaxoSmithKline

Hochgeladen am

11. April 2019

DOI

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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

Englisch

Concomitant Vaccination; Medication; Non-Serious Adverse Events; Study Conclusion; Tracking Document; Diary Card

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Beschreibung

If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C3174092
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0439568
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade/ (Generic) Name
Beschreibung

Trade/ (Generic) Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C0592502
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Administration Date
Beschreibung

Administration Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Beschreibung

If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1533734
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C3174092
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0439568
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Trade/ Generic Name
Beschreibung

Trade/ Generic Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0592502
Medical Indication
Beschreibung

Medical Indication

Datentyp

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

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

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Beschreibung

Tick box if continuing at end of study

Datentyp

integer

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0687676
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Events Description
Beschreibung

Non-Serious Adverse Events Description

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Non-Serious Adverse Events location
Beschreibung

Non-Serious Adverse Events location

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
Date Non-Serious Adverse Events Started
Beschreibung

Date Non-Serious Adverse Events Started

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
Beschreibung

Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date Non-Serious Adverse Event Stopped
Beschreibung

Date Non-Serious Adverse Event Stopped

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event Intensity
Beschreibung

Non-Serious Adverse Event Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Non-Serious Adverse Event Relationship
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
Non-Serious Adverse Experience Outcome
Beschreibung

Non-Serious Adverse Experience Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject experience any Serious Adverse Event since the additional vaccination visit?
Beschreibung

If yes, specify total number of SAE's

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C1524062
Number of SAE's
Beschreibung

Number of SAE's

Datentyp

integer

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

If yes, complete the Pregnancy Notification form.

Datentyp

integer

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

If yes, record major reason for withdrawal (tick one box only)

Datentyp

boolean

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

Tick one box only

Datentyp

text

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

Please complete and submit SAE report

Datentyp

integer

If Non-serious adverse event, please specify AE No or solicited AE code.
Beschreibung

Please complete Non-serious Adverse Event section

Datentyp

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
Beschreibung

If protocol violation, please specify

Datentyp

text

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

If other reason, please specify

Datentyp

text

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

Who made the decision?

Datentyp

text

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

Date of last contact

Datentyp

date

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

If No, please give details in Adverse Events section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tracking Document - Reason for non participation
Beschreibung

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C3889409
UMLS CUI-2
C0558080
UMLS CUI-3
C0679823
UMLS CUI-4
C0392360
Previous subject number
Beschreibung

Previous subject number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of birth
Beschreibung

Date of birth

Datentyp

date

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

Please document reason for non participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
If patient ist not eligible, please specify criteria that are not fulfilled
Beschreibung

If patient ist not eligible, please specify criteria that are not fulfilled

Datentyp

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C3828770
UMLS CUI [1,3]
C2348235
If subject is eligible but not willing to participate, specify reason
Beschreibung

If subject is eligible but not willing to participate, specify reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
If reason is adverse ebvent or serious adverse event, please specify.
Beschreibung

If reason is adverse ebvent or serious adverse event, please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C2348235
If subject is eligible but not willing to participate due to other reason, please specify
Beschreibung

If subject is eligible but not willing to participate due to other reason, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Subject died on:
Beschreibung

Subject died on

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Investigator name (please PRINT name)
Beschreibung

Investigator name (please PRINT name)

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Diary Card - Local Symptoms (at injection site)
Beschreibung

Diary Card - Local Symptoms (at injection site)

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Redness size - Day 0
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Redness size - Day 1
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Redness size - Day 2
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Redness size - Day 3
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Redness ongoing after Day 3?
Beschreibung

Redness ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing after Day 3, please record Date of last Day of Symptoms
Beschreibung

If Redness is ongoing after Day 3, please record Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Swelling size - Day 0
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling size - Day 1
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling size - Day 2
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling size - Day 3
Beschreibung

Please measure the greatest diameter (in mm).

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling ongoing after Day 3?
Beschreibung

Swelling ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing after Day 3, record Date of last Day of Symptoms
Beschreibung

If Swelling is ongoing after Day 3, record Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Pain intensity - Day 0
Beschreibung

Pain intensity - Day 0

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity - Day 1
Beschreibung

Pain intensity - Day 1

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity - Day 2
Beschreibung

Pain intensity - Day 2

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity - Day 3
Beschreibung

Pain intensity - Day 3

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Pain ongoing after Day3?
Beschreibung

Pain ongoing after Day3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If pain is ongoing after Day 3, record Date of last Day of Symptoms
Beschreibung

undefined item

Datentyp

date

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Diary Card - Other local symptoms
Beschreibung

Diary Card - Other local symptoms

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0205394
Description - please specify side(s) and site(s)
Beschreibung

Description - please specify side(s) and site(s)

Datentyp

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C2348235
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C2348235
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Symptom Start date
Beschreibung

Symptom Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
Symptom End date
Beschreibung

Symptom End date

Datentyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
Check box if continuing
Beschreibung

Check box if continuing

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Diary Card - Medication
Beschreibung

Diary Card - Medication

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C3174772
Trade / Generic Name
Beschreibung

Trade / Generic Name

Datentyp

text

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

Reason for medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Medication Start date
Beschreibung

Medication Start date

Datentyp

date

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

Medication End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check box, if medication is continuing
Beschreibung

Check box, if medication is continuing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Diaray Card - General Symptoms
Beschreibung

Diaray Card - General Symptoms

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0159028
Temperature Route
Beschreibung

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.

Datentyp

integer

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

Temperature - Day 0

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature - Day 1
Beschreibung

Temperature - Day 1

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature - Day 2
Beschreibung

Temperature - Day 2

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature - Day 3
Beschreibung

Temperature - Day 3

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature ongoing after Day 3?
Beschreibung

Temperature ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3174772
If Temperature is ongoing after Day 3, record Date of last Date of Symptoms
Beschreibung

If Temperature is ongoing after Day 3, record Date of last Date of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1517741
UMLS CUI [1,5]
C1457887
Fatigue intensity - Day 0
Beschreibung

Fatigue intensity - Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue intensity - Day 1
Beschreibung

Fatigue intensity - Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue intensity - Day 2
Beschreibung

Fatigue intensity - Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue intensity - Day 3
Beschreibung

Fatigue intensity - Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue ongoing after Day 3?
Beschreibung

Fatigue ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3174772
If Fatigue is ongoing after Day 3, record Date of last Day of Symptoms
Beschreibung

If Fatigue is ongoing after Day 3, record Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Headache intensity - Day 0
Beschreibung

Headache intensity - Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache intensity - Day 1
Beschreibung

Headache intensity - Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache intensity - Day 2
Beschreibung

Headache intensity - Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache intensity - Day 3
Beschreibung

Headache intensity - Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Is Headache ongoing after Day 3?
Beschreibung

Is Headache ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C3174772
If Headache is ongoing after Day 3, record Date of last Day of Symptoms
Beschreibung

If Headache is ongoing after Day 3, record Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Gastrointestinal symptoms intensity - Day 0
Beschreibung

Gastrointestinal symptoms intensity - Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms intensity - Day 1
Beschreibung

Gastrointestinal symptoms intensity - Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms intensity - Day 2
Beschreibung

Gastrointestinal symptoms intensity - Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms intensity - Day 3
Beschreibung

Gastrointestinal symptoms intensity - Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms ongoing after Day 3?
Beschreibung

Gastrointestinal symptoms ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C3174772
If Gastrointestinal symptoms are ongoing after Day 3, record Date of last Day of Symptoms
Beschreibung

If Gastrointestinal symptoms are ongoing after Day 3, record Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Diary Card - Other general Symptoms
Beschreibung

Diary Card - Other general Symptoms

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

Description - please give details below

Datentyp

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2]
C1522508
Symptom intensity
Beschreibung

Symptom intensity

Datentyp

text

Alias
UMLS CUI [1]
C0518690
Symptom Start Date
Beschreibung

Symptom Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
Symptom End Date
Beschreibung

Symptom End Date

Datentyp

date

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

Check box, if symptoms are continuing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Concomitant Vaccination; Medication; Non-Serious Adverse Events; Study Conclusion; Tracking Document; Diary Card

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Item
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
boolean
C2368628 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0439568 (UMLS CUI [3,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade/ (Generic) Name
Item
Trade/ (Generic) Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Inhalation  (IH)
CL Item
Intramuscular  (IM)
CL Item
Intravenous  (IV)
CL Item
Intranasal  (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
Item
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after the vaccine dose?
boolean
C0013227 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0439568 (UMLS CUI [3,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
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
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Tick box if continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Tick box if continuing at end of study
Code List
Tick box if continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Events Description
Item
Non-Serious Adverse Events Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Events location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-Serious Adverse Experiences location
Code List
Non-Serious Adverse Events location
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Date Non-Serious Adverse Events Started
Item
Date Non-Serious Adverse Events Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Start Date during immediate post-vaccination period specified in protocol
Code List
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
CL Item
Start Date during immediate post-vaccination period (30 minutes) (1)
Date Non-Serious Adverse Event Stopped
Item
Date Non-Serious Adverse Event Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Intensity
Code List
Non-Serious Adverse Event Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-Serious Adverse Event Relationship
Item
Non-Serious Adverse Event Relationship
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Experience Outcome
Code List
Non-Serious Adverse Experience Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Did the subject experience any Serious Adverse Event since the additional vaccination visit?
Item
Did the subject experience any Serious Adverse Event since the additional vaccination visit?
boolean
C1519255 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
Number of SAE's
Item
Number of SAE's
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Did the become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Did the become pregnant during the study?
Code List
Did the become pregnant during the study?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (not of childbearing potential or male) (3)
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
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
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Tracking Document - Reason for non participation
C3889409 (UMLS CUI-1)
C0558080 (UMLS CUI-2)
C0679823 (UMLS CUI-3)
C0392360 (UMLS CUI-4)
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (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 document reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not fullfilled (1)
CL Item
Subject lost to follow-up or not reached  (2)
CL Item
Subject eligible but not willing to participate - please specify reason (3)
CL Item
Subject died - please record date (4)
If patient ist not eligible, please specify criteria that are not fulfilled
Item
If patient ist 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
If subject is eligible but not willing to participate, specify reason
integer
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
If subject is eligible but not willing to participate, specify reason
Code List
If subject is eligible but not willing to participate, specify reason
CL Item
Adverse events, or serious adverse event - please specify (1)
CL Item
Other - please specify (2)
If reason is adverse ebvent or serious adverse event, please specify.
Item
If reason is adverse ebvent or serious adverse event, please specify.
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject is eligible but not willing to participate due to other reason, please specify
Item
If subject is eligible but not willing to participate due to other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Subject died on
Item
Subject died on:
date
C1148348 (UMLS CUI [1])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Investigator name (please PRINT name)
Item
Investigator name (please PRINT name)
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Diary Card - Local Symptoms (at injection site)
C3890583 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Redness size - Day 0
Item
Redness size - Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Redness size - Day 1
Item
Redness size - Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Redness size - Day 2
Item
Redness size - Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Redness size - Day 3
Item
Redness size - Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (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 after Day 3, please record Date of last Day of Symptoms
Item
If Redness is ongoing after Day 3, please record Date of last Day of Symptoms
date
C0332575 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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 after Day 3, record Date of last Day of Symptoms
Item
If Swelling is ongoing after Day 3, record Date of last Day of Symptoms
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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)
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)
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)
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)
Pain ongoing after Day3?
Item
Pain ongoing after Day3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
undefined item
Item
If pain is ongoing after Day 3, record Date of last Day of Symptoms
date
C0030193 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item Group
Diary Card - Other local symptoms
C3890583 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0678257 (UMLS CUI [1])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
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. (3)
CL Item
(In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (4)
Symptom Start date
Item
Symptom Start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptom End date
Item
Symptom End date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box if continuing
integer
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Check box if continuing
Code List
Check box if continuing
CL Item
Symptoms Continuing (1)
Item Group
Diary Card - Medication
C1457887 (UMLS CUI-1)
C3174772 (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
Item
Medication End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box, if medication is continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Check box, if medication is continuing
Code List
Check box, if medication is continuing
CL Item
Medication is continuing (1)
Item Group
Diaray Card - General Symptoms
C3890583 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Temperature - Day 0
Item
Temperature - Day 0
float
C0005903 (UMLS CUI [1])
Temperature - Day 1
Item
Temperature - Day 1
float
C0005903 (UMLS CUI [1])
Temperature - Day 2
Item
Temperature - Day 2
float
C0005903 (UMLS CUI [1])
Temperature - Day 3
Item
Temperature - Day 3
float
C0005903 (UMLS CUI [1])
Temperature ongoing after Day 3?
Item
Temperature ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Temperature is ongoing after Day 3, record Date of last Date of Symptoms
Item
If Temperature is ongoing after Day 3, record Date of last Date of Symptoms
date
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,5])
Item
Fatigue intensity - Day 0
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity - Day 0
Code List
Fatigue intensity - Day 0
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
Fatigue intensity - Day 1
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity - Day 1
Code List
Fatigue intensity - Day 1
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
Fatigue intensity - Day 2
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity - Day 2
Code List
Fatigue intensity - Day 2
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
Fatigue intensity - Day 3
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity - Day 3
Code List
Fatigue intensity - Day 3
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)
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 after Day 3, record Date of last Day of Symptoms
Item
If Fatigue is ongoing after Day 3, record Date of last Day of Symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Headache intensity - Day 0
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache intensity - Day 0
Code List
Headache intensity - Day 0
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
Headache intensity - Day 1
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache intensity - Day 1
Code List
Headache intensity - Day 1
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
Headache intensity - Day 2
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache intensity - Day 2
Code List
Headache intensity - Day 2
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
Headache intensity - Day 3
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache intensity - Day 3
Code List
Headache intensity - Day 3
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)
Is Headache ongoing after Day 3?
Item
Is Headache ongoing after Day 3?
boolean
C0018681 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Headache is ongoing after Day 3, record Date of last Day of Symptoms
Item
If Headache is ongoing after Day 3, record Date of last Day of Symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Gastrointestinal symptoms intensity - Day 0
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity - Day 0
Code List
Gastrointestinal symptoms intensity - Day 0
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)
Item
Gastrointestinal symptoms intensity - Day 1
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal samptoms intensity - Day 1
Code List
Gastrointestinal symptoms intensity - Day 1
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)
Item
Gastrointestinal symptoms intensity - Day 2
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity - Day 2
Code List
Gastrointestinal symptoms intensity - Day 2
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)
Item
Gastrointestinal symptoms intensity - Day 3
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity - Day 3
Code List
Gastrointestinal symptoms intensity - Day 3
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)
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 after Day 3, record Date of last Day of Symptoms
Item
If Gastrointestinal symptoms are ongoing after Day 3, record Date of last Day of Symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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])
C1522508 (UMLS CUI [2])
Item
Symptom intensity
text
C0518690 (UMLS CUI [1])
Symptom intensity
Code List
Symptom 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. (3)
CL Item
(In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). ((In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).)
Symptom Start Date
Item
Symptom Start Date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptom End Date
Item
Symptom End Date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box, if symptoms are continuing
integer
C0159028 (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 are continuing (1)
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