ID

25186

Beschrijving

Diary Card - Varicella /Zoster Case - 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

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Versies (1)
  1. 28-08-17 28-08-17 -
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glaxoSmithKline

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28 augustus 2017

DOI

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Creative Commons BY-NC 3.0
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Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

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Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulieren  
Rash
Beschrijving

Rash

Alias
UMLS CUI-1
C0015230
Date rash onset
Beschrijving

date when first lesion appears

Datatype

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0574845
Date rash end
Beschrijving

date of first day when no new lesions appear

Datatype

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
Lesion
Beschrijving

Lesion

Alias
UMLS CUI-1
C0221198
Day
Beschrijving

Day 0-14 Day 0 should be date rash onset - Complete until date rash end

Datatype

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0221198
Daily number of overall Lesions
Beschrijving

Daily number of overall Lesions

Datatype

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0332173
Vesicles
Beschrijving

Vesicles

Alias
UMLS CUI-1
C0333262
Day
Beschrijving

Day 0 should be date rash onset - Complete until date rash end

Datatype

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0333262
Daily number of overall Vesicles
Beschrijving

Estimation of the DAILY number of vesicles (=lesions with fluid in them) according to the following ranges

Datatype

integer

Alias
UMLS CUI [1,1]
C0333262
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0332173
Temperature
Beschrijving

Temperature

Alias
UMLS CUI-1
C0039476
Route
Beschrijving

Please record all temperatures from date rash onset till date rash end Note: → If multiple measurements during a day, record the highest temperature → Only one route of temperature measurement should be used consistently

Datatype

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Temperature
Beschrijving

Temperature

Alias
UMLS CUI-1
C0039476
Day
Beschrijving

Day 0-14 Please record all temperatures from date rash onset till date rash end Note: → If multiple measurements during a day, record the highest temperature → Only one route of temperature measurement should be used consistently

Datatype

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0039476
Date
Beschrijving

Date Temperature

Datatype

date

Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0011008
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • degree Celsius
Alias
UMLS CUI [1]
C0039476
degree Celsius
Not taken
Beschrijving

Temperature not taken

Datatype

boolean

Alias
UMLS CUI [1]
C0039476
Weekdays location
Beschrijving

Weekdays location

Alias
UMLS CUI-1
C0450429
UMLS CUI-2
C0680189
Daycare
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

boolean

Alias
UMLS CUI [1]
C0008070
Daycare: Frequency: number of days?
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

integer

Alias
UMLS CUI [1,1]
C0008070
UMLS CUI [1,2]
C0439603
Home
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

boolean

Alias
UMLS CUI [1]
C0442519
Home: Frequency: number of days?
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

integer

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C0439603
School
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

boolean

Alias
UMLS CUI [1]
C0036375
School: Frequency: number of days?
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

integer

Alias
UMLS CUI [1,1]
C0036375
UMLS CUI [1,2]
C0439603
Childminder
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

boolean

Alias
UMLS CUI [1]
C0730005
Childminder: Frequency: number of days?
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

integer

Alias
UMLS CUI [1,1]
C0730005
UMLS CUI [1,2]
C0439603
Number of children at childminder
Beschrijving

Number of children at childminder

Datatype

integer

Alias
UMLS CUI [1,1]
C0730005
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C0449788
Number of children with negative varicella history?
Beschrijving

at childminder

Datatype

integer

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0455469
Number of children with negative varicella history unknown.
Beschrijving

Number of children with negative varicella history unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0455469
Other, specify:
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other location
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
Other location: Frequency: number of days?
Beschrijving

Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).

Datatype

integer

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0439603
Varicella or zoster index case
Beschrijving

Varicella or zoster index case

Alias
UMLS CUI-1
C2597943
UMLS CUI-2
C0008049
UMLS CUI-4
C2597943
UMLS CUI-5
C0740380
In last 30 days - prior to onset of varicella (chickenpox) or zoster case (shingles) - was there a recognized exposure of the subject with an index case, was there a recognized exposure of your child with index case?
Beschrijving

Varicella or zoster index case

Datatype

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0008049
UMLS CUI [2,1]
C2597943
UMLS CUI [2,2]
C0740380
Type of contact
Beschrijving

Type of contact

Datatype

integer

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0332307
Frequency
Beschrijving

Frequency of contact

Datatype

integer

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0439603
Date of contact
Beschrijving

Only answer if you choose "occasional contact"

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0008049
Nature of contact
Beschrijving

Nature of contact

Datatype

integer

Alias
UMLS CUI [1,1]
C0392367
UMLS CUI [1,2]
C0332307
Other: specify
Beschrijving

Specify other kind of contact

Datatype

text

Alias
UMLS CUI [1,1]
C0392367
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Date varicella or zoster end
Beschrijving

Date varicella or zoster end

Alias
UMLS CUI-1
C0008049
UMLS CUI-2
C0806020
UMLS CUI-4
C0740380
UMLS CUI-5
C0806020
Date end of varicella (chickenpox)/ zoster (shingles)
Beschrijving

date when subject resumes normal everyday activities.

Datatype

date

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C0806020
Health economics
Beschrijving

Health economics

Alias
UMLS CUI-1
C0013556
UMLS CUI-2
C0018684
Did you, as parent/guardian, or your family members, lose time from work as a result of taking care of your child during this illness?
Beschrijving

work time lost due to care taking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0237107
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0585074
How many hours?
Beschrijving

Only answer if you answered previous question with 'yes'. How many hours did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness ?

Datatype

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0030551
Did your child lose any days in the day care / childminder / school attendance or any extra-curricular activities (e.g. sports or recreation or any type of organized leisure activities) during this illness?
Beschrijving

time lost at day care / childminder / school attendance / extracurricular activity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2185951
UMLS CUI [1,2]
C0008070
UMLS CUI [2,1]
C2185951
UMLS CUI [2,2]
C0730005
UMLS CUI [3,1]
C2185951
UMLS CUI [3,2]
C0036375
UMLS CUI [4,1]
C2185951
UMLS CUI [4,2]
C0681383
How many hours?
Beschrijving

Only answer if you answered previous question with 'yes'. How many hours did the subject lose in the day care / childminder / school attendance or at extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) during this illness?

Datatype

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0008059
Did you request assistance from a nurse, a babysitter or any type of paid caregiver to look after your child during this illness?
Beschrijving

Assistance needed by nurse, babysitter or any type of paid caregiver

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840284
UMLS CUI [1,2]
C0028661
UMLS CUI [2,1]
C3840284
UMLS CUI [2,2]
C0337606
UMLS CUI [3,1]
C3840284
UMLS CUI [3,2]
C0085537
How many hours?
Beschrijving

How many hours 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?

Datatype

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0085537
If your child were not participating in this trial, would you, as parents / guardians, have contacted or visited a physician to seek medical advice for this illness?
Beschrijving

Parents seeking medical advice for illness

Datatype

boolean

Alias
UMLS CUI [1,1]
C1386497
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C2348568
Pain
Beschrijving

Pain

Alias
UMLS CUI-1
C0030193
Did the child present any back or abdominal pain during this illness?
Beschrijving

back or abdominal pain varicella or zoster

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004604
UMLS CUI [1,2]
C0008049
UMLS CUI [1,3]
C0740380
UMLS CUI [2,1]
C0000737
UMLS CUI [2,2]
C0008049
UMLS CUI [2,3]
C0740380
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Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Rash
C0015230 (UMLS CUI-1)
Date rash onset
Item
Date rash onset
date
C0015230 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Date rash end
Item
Date rash end
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Lesion
C0221198 (UMLS CUI-1)
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
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])
Daily number of overall Lesions
Code List
Daily number of overall Lesions
CL Item
1-50 (1)
CL Item
51-100 (2)
CL Item
101-500 (3)
CL Item
>500 (4)
Item Group
Vesicles
C0333262 (UMLS CUI-1)
Day
Item
Day
text
C0439228 (UMLS CUI [1,1])
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])
undefined item
Code List
Daily number of overall Vesicles
CL Item
None (1)
CL Item
1-10 (2)
CL Item
11-50 (3)
CL Item
>50 (4)
Item Group
Temperature
C0039476 (UMLS CUI-1)
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route body temperature
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item Group
Temperature
C0039476 (UMLS CUI-1)
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Date Temperature
Item
Date
date
C0039476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Temperature not taken
Item
Not taken
boolean
C0039476 (UMLS CUI [1])
Item Group
Weekdays location
C0450429 (UMLS CUI-1)
C0680189 (UMLS CUI-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])
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])
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])
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])
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])
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])
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])
specify other location
Item
Other, specify:
text
C0450429 (UMLS CUI [1,1])
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])
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])
Item Group
Varicella or zoster index case
C2597943 (UMLS CUI-1)
C0008049 (UMLS CUI-2)
C2597943 (UMLS CUI-4)
C0740380 (UMLS CUI-5)
Varicella or zoster index case
Item
In last 30 days - prior to onset of varicella (chickenpox) or zoster case (shingles) - was there a recognized exposure of the subject with an index case, was there a recognized exposure of your child with index case?
boolean
C2597943 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
Item
Type of contact
integer
C0332158 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of contact
Code List
Type of contact
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])
Frequency of contact
Code List
Frequency
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])
Item
Nature of contact
integer
C0392367 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Nature of contact
Code List
Nature of contact
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])
Item Group
Date varicella or zoster end
C0008049 (UMLS CUI-1)
C0806020 (UMLS CUI-2)
C0740380 (UMLS CUI-4)
C0806020 (UMLS CUI-5)
End Date Varicella or zoster
Item
Date end of varicella (chickenpox)/ zoster (shingles)
date
C0008049 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item Group
Health economics
C0013556 (UMLS CUI-1)
C0018684 (UMLS CUI-2)
work time lost due to care taking
Item
Did you, as parent/guardian, or your family members, lose time from work as a result of taking care of your child during this illness?
boolean
C0237107 (UMLS CUI [1,1])
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])
time lost at day care / childminder / school attendance / extracurricular activity
Item
Did your child lose any days in the day care / childminder / school attendance or any extra-curricular activities (e.g. sports or recreation or any type of organized 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])
Amount of hours
Item
How many hours?
integer
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
Assistance needed by nurse, babysitter or any type of paid caregiver
Item
Did you request assistance from a nurse, a babysitter or any type of paid caregiver to look after your child 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])
Amount of hours
Item
How many hours?
integer
C0439227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0085537 (UMLS CUI [1,3])
Parents seeking medical advice for illness
Item
If your child were not participating in this trial, would you, as 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])
Item Group
Pain
C0030193 (UMLS CUI-1)
back or abdominal pain varicella or zoster
Item
Did the child present any back or abdominal pain during this illness?
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])
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