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ID
25397
Descrição
Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella
Palavras-chave
Versões (1)
- 03-09-17 03-09-17 -
Titular dos direitos
glaxoSmithKline
Transferido a
3 september 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499
Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499
Similar models
Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Varicella or zoster case
C0008049 (UMLS CUI-1)
C0740380 (UMLS CUI-2)
C0740380 (UMLS CUI-2)
Varicella or zoster case
Item
Has any varicella or Zoster case occurred during the study period ?
boolean
C0008049 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0740380 (UMLS CUI [1,2])
Date telephone contact with investigator
Item
Date telephone contact from parents/guardians to investigators
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Date of investigator visit
Item
Date of investigator visit
date
C1512346 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Varicella (1)
CL Item
Zoster (2)
Macular varicella
Item
Macular Type
boolean
C0008049 (UMLS CUI [1,1])
C0221201 (UMLS CUI [1,2])
C0221201 (UMLS CUI [1,2])
Papular Varicella
Item
Papular Type
boolean
C0008049 (UMLS CUI [1,1])
C1519353 (UMLS CUI [1,2])
C1519353 (UMLS CUI [1,2])
vesicular varicella
Item
Mostly vesicular type
boolean
C0008049 (UMLS CUI [1,1])
C0221203 (UMLS CUI [1,2])
C0221203 (UMLS CUI [1,2])
Hemorrhagic varicella
Item
Hemorrhagic type
boolean
C0008049 (UMLS CUI [1,1])
C0235498 (UMLS CUI [1,2])
C0235498 (UMLS CUI [1,2])
Item Group
Intensity - Lesions and vesicles
C0008049 (UMLS CUI-1)
C0234687 (UMLS CUI-2)
C0234687 (UMLS CUI-2)
Date lesions are examined
Item
Date
date
C0221198 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Daily number of overall lesions
integer
C0221198 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
CL Item
1-50 (1)
CL Item
51-100 (2)
CL Item
101-500 (3)
CL Item
>500 (4)
Item
Daily number of overall vesicles
integer
C3814530 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
1-10 (2)
CL Item
11-50 (3)
CL Item
>50 (4)
Item Group
Subjective assessment of the illness by investigator
C0221423 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0035173 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C0035173 (UMLS CUI-3)
Item
Please give the subjective assessment of the illness
integer
C0221423 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Code List
Please give the subjective assessment of the illness
CL Item
Subject does not appear ill (1)
CL Item
Subject appears moderately ill (2)
CL Item
Subject appears severely ill (3)
photographs been taken
Item
Have photographs been taken?
boolean
C0441468 (UMLS CUI [1])
Dates of photographs
Item
Dates of photographs
text
C0441468 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
how many photographs
Item
How many photographs have been taken?
integer
C0441468 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Daycare
Item
Daycare
boolean
C0008070 (UMLS CUI [1])
Frequency of time spend in daycare
Item
Daycare: Frequency: number of days?
integer
C0008070 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Home
Item
Home
boolean
C0442519 (UMLS CUI [1])
Frequency of time spend at home
Item
Home: Frequency: number of days?
integer
C0442519 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
School
Item
School
boolean
C0036375 (UMLS CUI [1])
Frequency of time spend at school
Item
School: Frequency: number of days?
integer
C0036375 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Childminder
Item
Childminder
boolean
C0730005 (UMLS CUI [1])
Frequency of time spend at childminder
Item
Childminder: Frequency: number of days?
integer
C0730005 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Number of children at childminder
Item
Number of children at childminder
integer
C0730005 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0008059 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of children with negative varicella history
Item
Number of children with negative varicella history?
integer
C0008059 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
Number of children with negative varicella history unknown
Item
Number of children with negative varicella history unknown.
boolean
C0008059 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
specify other location
Item
Other, specify:
text
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other location
Item
Other location
boolean
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Frequency of time spend at other location
Item
Other location: Frequency: number of days?
integer
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Item Group
Varicella or zoster index case
C2597943 (UMLS CUI-1)
C0008049 (UMLS CUI-2)
C2597943 (UMLS CUI-4)
C0740380 (UMLS CUI-5)
C0008049 (UMLS CUI-2)
C2597943 (UMLS CUI-4)
C0740380 (UMLS CUI-5)
Varicella or zoster index case
Item
In the last 30 days (prior to onset of varicella or zoster case), was there a recognized exposure of the subject with an index case?
boolean
C2597943 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
C0008049 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
CL Item
Varicella (1)
CL Item
Zoster (2)
Item
Frequency
integer
C0008049 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0332158 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
CL Item
Occasional contact (1)
CL Item
Daily contact (2)
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0008049 (UMLS CUI [1,3])
C0332158 (UMLS CUI [1,2])
C0008049 (UMLS CUI [1,3])
Item
Nature of contact
integer
C0392367 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Household (1)
CL Item
Daycare center (2)
CL Item
Childminder (3)
CL Item
Playmate (4)
CL Item
School (in the same building) (5)
CL Item
School (in a different building) (6)
CL Item
Classroom (7)
CL Item
Other: specify (8)
Specify other kind of contact
Item
Other: specify
text
C0392367 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Confirmation of index case
C2597943 (UMLS CUI-1)
C0521091 (UMLS CUI-2)
C0521091 (UMLS CUI-2)
Local laboratory confirmed index case
Item
Local laboratory confirmed
boolean
C0011911 (UMLS CUI [1,1])
C2597943 (UMLS CUI [1,2])
C2597943 (UMLS CUI [1,2])
Diagnosis of index case by a physician
Item
Diagnosis by a physician (whenever the physician's diagnosis of the index case is retrievable by the investigator)
boolean
C2597943 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
Index case confirmed at part of a school / day care center / institutional outbreak
Item
Part of a school / day care center / institutional outbreak for which confirmation can be obtained by the investigator from competent health authorities (e.g. school health service, school nurse or official surveillance network run by health authorities, as applicable)
boolean
C2597943 (UMLS CUI [1,1])
C0036375 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0008070 (UMLS CUI [2,2])
C2597943 (UMLS CUI [3,1])
C0012652 (UMLS CUI [3,2])
C1272753 (UMLS CUI [3,3])
C0036375 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0008070 (UMLS CUI [2,2])
C2597943 (UMLS CUI [3,1])
C0012652 (UMLS CUI [3,2])
C1272753 (UMLS CUI [3,3])
Diagnosis of index case by investigator
Item
Diagnosis by investigator
boolean
C2597943 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Confirmed by index-case parents
Item
By index-case parents
boolean
C2597943 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0030551 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
Index case not confirmed
Item
Not confirmed
boolean
C2597943 (UMLS CUI [1,1])
C0521092 (UMLS CUI [1,2])
C0521092 (UMLS CUI [1,2])
Item Group
Biological sample
C2347026 (UMLS CUI-1)
C0042338 (UMLS CUI-2)
C0042338 (UMLS CUI-2)
Biological sample varicella
Item
Have biological samples been taken?
boolean
C2347026 (UMLS CUI [1,1])
C0042338 (UMLS CUI [1,2])
C0042338 (UMLS CUI [1,2])
Item Group
Biological sample
C2347026 (UMLS CUI-1)
C0042338 (UMLS CUI-2)
C0042338 (UMLS CUI-2)
Date sample has been taken
Item
Date
date
C2347026 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Sequential Number
Item
Sequential Number
integer
C0237753 (UMLS CUI [1,1])
C1705294 (UMLS CUI [1,2])
C1705294 (UMLS CUI [1,2])
CL Item
Vesicle (1)
CL Item
Papule (2)
CL Item
Crust (3)
CL Item
Throat (4)
Last 4 digits of Label Code Bar
Item
Last 4 digits of Label Code Bar
integer
C0600091 (UMLS CUI [1,1])
C3241971 (UMLS CUI [1,2])
C3241971 (UMLS CUI [1,2])
Date rash onset
Item
Date rash onset
date
C0015230 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Date rash end
Item
Date rash end
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Item
Daily number of overall Lesions
integer
C0221198 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
CL Item
1-50 (1)
CL Item
51-100 (2)
CL Item
101-500 (3)
CL Item
>500 (4)
Day
Item
Day
text
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0333262 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0333262 (UMLS CUI [1,3])
Item
Daily number of overall Vesicles
integer
C0333262 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
1-10 (2)
CL Item
11-50 (3)
CL Item
>50 (4)
CL Item
Axillary (A)
CL Item
Rectal (R)
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Temperature not taken
Item
Not taken
boolean
C0039476 (UMLS CUI [1])
Item Group
Date varicella or zoster end
C0008049 (UMLS CUI-1)
C0806020 (UMLS CUI-2)
C0740380 (UMLS CUI-4)
C0806020 (UMLS CUI-5)
C0806020 (UMLS CUI-2)
C0740380 (UMLS CUI-4)
C0806020 (UMLS CUI-5)
End Date Varicella or zoster
Item
Date varicella or zoster end
date
C0008049 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
work time lost due to care taking
Item
Did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness?
boolean
C0237107 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0585074 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0585074 (UMLS CUI [1,3])
Amount of hours
Item
How many hours?
integer
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
time lost at day care / childminder / school attendance / extracurricular activity
Item
Did the subject lose any days in the day care / childminder / school attendance or any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) during this illness ?
boolean
C2185951 (UMLS CUI [1,1])
C0008070 (UMLS CUI [1,2])
C2185951 (UMLS CUI [2,1])
C0730005 (UMLS CUI [2,2])
C2185951 (UMLS CUI [3,1])
C0036375 (UMLS CUI [3,2])
C2185951 (UMLS CUI [4,1])
C0681383 (UMLS CUI [4,2])
C0008070 (UMLS CUI [1,2])
C2185951 (UMLS CUI [2,1])
C0730005 (UMLS CUI [2,2])
C2185951 (UMLS CUI [3,1])
C0036375 (UMLS CUI [3,2])
C2185951 (UMLS CUI [4,1])
C0681383 (UMLS CUI [4,2])
Amount of hours
Item
How many hours?
integer
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
Assistance needed by nurse, babysitter or any type of paid caregiver
Item
Did the parents / guardians request assistance from a nurse, a babysitter or any type of paid caregiver to look after the subject during this illness ?
boolean
C3840284 (UMLS CUI [1,1])
C0028661 (UMLS CUI [1,2])
C3840284 (UMLS CUI [2,1])
C0337606 (UMLS CUI [2,2])
C3840284 (UMLS CUI [3,1])
C0085537 (UMLS CUI [3,2])
C0028661 (UMLS CUI [1,2])
C3840284 (UMLS CUI [2,1])
C0337606 (UMLS CUI [2,2])
C3840284 (UMLS CUI [3,1])
C0085537 (UMLS CUI [3,2])
Amount of hours
Item
How many hours?
integer
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0085537 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0085537 (UMLS CUI [1,3])
Parents seeking medical advice for illness
Item
If the subject were not participating in this trial, would the parents / guardians have contacted or visited a physician to seek medical advice for this illness ?
boolean
C1386497 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0030551 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
back or abdominal pain varicella or zoster
Item
Did the subject present any back or abdominal pain during this varicella or zoster case ?
boolean
C0004604 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0740380 (UMLS CUI [1,3])
C0000737 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
C0740380 (UMLS CUI [2,3])
C0008049 (UMLS CUI [1,2])
C0740380 (UMLS CUI [1,3])
C0000737 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
C0740380 (UMLS CUI [2,3])
complications
Item
Any complications as listed in the Protocol ?
boolean
C0009566 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse event (complete the Serious Adverse Event form)
boolean
Number of serious adverse events
Item
Please specify SAE No:
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Treatment given for varicella or zoster
Item
Was any treatment given for the varicella or zoster case ?
boolean
C0087111 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
C0008049 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
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