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ID
36044
Beschrijving
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
Trefwoorden
Versies (1)
- 11-04-19 11-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 april 2019
DOI
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Licentie
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
Concomitant Vaccination; Medication; Non-Serious Adverse Events; Study Conclusion; Tracking Document; Diary Card
Similar models
Concomitant Vaccination; Medication; Non-Serious Adverse Events; Study Conclusion; Tracking Document; Diary Card
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
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])
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)
C2347852 (UMLS CUI-2)
Trade/ (Generic) Name
Item
Trade/ (Generic) Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
C0592502 (UMLS CUI [2])
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])
C0011008 (UMLS CUI [1,2])
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])
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])
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
C0592502 (UMLS CUI [1,2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
Prophylactic (1)
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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])
C2983670 (UMLS CUI [1,2])
CL Item
Continuing at end of study (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])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Non-Serious Adverse Events Description
Item
Non-Serious Adverse Events Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Events location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
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])
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])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
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])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
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])
C0439849 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
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)
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])
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])
C1519255 (UMLS CUI [1,2])
Item
Did the become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
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])
C0392360 (UMLS CUI [1,2])
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])
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])
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])
C2348235 (UMLS CUI [1,2])
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])
C0681850 (UMLS CUI [1,2])
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])
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)
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])
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])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
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])
C0392360 (UMLS CUI [1,2])
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])
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])
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])
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)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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)
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)
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)
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])
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])
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)
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])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
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])
C0808070 (UMLS CUI [1,2])
Symptom End date
Item
Symptom End date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Check box if continuing
integer
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
CL Item
Symptoms Continuing (1)
Item Group
Diary Card - Medication
C1457887 (UMLS CUI-1)
C3174772 (UMLS CUI-2)
C3174772 (UMLS CUI-2)
Trade / Generic Name
Item
Trade / Generic Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
C0592502 (UMLS CUI [2])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
Medication Start date
Item
Medication Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Medication End date
Item
Medication End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Check box, if medication is continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
Medication is continuing (1)
Item Group
Diaray Card - General Symptoms
C3890583 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
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])
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])
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])
C0522510 (UMLS CUI [1,2])
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 1
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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 2
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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])
C0522510 (UMLS CUI [1,2])
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)
Fatigue ongoing after Day 3?
Item
Fatigue ongoing after Day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
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])
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])
C0522510 (UMLS CUI [1,2])
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 1
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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 2
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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])
C0522510 (UMLS CUI [1,2])
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)
Is Headache ongoing after Day 3?
Item
Is Headache ongoing after Day 3?
boolean
C0018681 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
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])
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])
C0522510 (UMLS CUI [1,2])
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 1
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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 2
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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])
C0522510 (UMLS CUI [1,2])
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)
Gastrointestinal symptoms ongoing after Day 3?
Item
Gastrointestinal symptoms ongoing after Day 3?
boolean
C0426576 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
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])
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)
C0029625 (UMLS CUI-2)
Description - please give details below
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
C1522508 (UMLS CUI [2])
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])
C0808070 (UMLS CUI [1,2])
Symptom End Date
Item
Symptom End Date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Check box, if symptoms are continuing
integer
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
Symptoms are continuing (1)