ID

25260

Descripción

Phase A - Year 1 - 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

Palabras clave

Versiones (1)
  1. 29/8/17 29/8/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

29 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Inglés

Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 formularios  
Varicella or zoster case
Descripción

Varicella or zoster case

Alias
UMLS CUI-1
C0008049
UMLS CUI-2
C0740380
Has any varicella or Zoster case occurred during the study period ?
Descripción

If yes, please complete below

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0740380
Date telephone contact from parents/guardians to investigators
Descripción

Date telephone contact with investigator

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0011008
Date of investigator visit
Descripción

Date of investigator visit

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0011008
Description
Descripción

Description

Tipo de datos

integer

Alias
UMLS CUI [1]
C0517733
Macular Type
Descripción

Macular varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221201
Papular Type
Descripción

Papular Varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C1519353
Mostly vesicular type
Descripción

vesicular varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221203
Hemorrhagic type
Descripción

Hemorrhagic varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0235498
Intensity - Lesions and vesicles
Descripción

Intensity - Lesions and vesicles

Alias
UMLS CUI-1
C0008049
UMLS CUI-2
C0234687
Date
Descripción

Date lesions are examined

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0011008
Daily number of overall lesions
Descripción

Daily number of overall lesions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0332173
Daily number of overall vesicles
Descripción

Daily number of overall vesicles

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3814530
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0332173
Subjective assessment of the illness by investigator
Descripción

Subjective assessment of the illness by investigator

Alias
UMLS CUI-1
C0221423
UMLS CUI-2
C0220825
UMLS CUI-3
C0035173
Please give the subjective assessment of the illness
Descripción

Subjective assessment of the illness by investigator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0035173
Photographs
Descripción

Photographs

Alias
UMLS CUI-1
C0441468
Have photographs been taken?
Descripción

photographs been taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0441468
Dates of photographs
Descripción

Dates of photographs

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0011008
How many photographs have been taken?
Descripción

how many photographs

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0449788
Weekdays location
Descripción

Weekdays location

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

integer

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case .

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

integer

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

integer

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

integer

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

Number of children at childminder

Tipo de datos

integer

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

at childminder

Tipo de datos

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.
Descripción

Number of children with negative varicella history unknown

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case

Tipo de datos

text

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case.

Tipo de datos

boolean

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

Record whereabouts of subject during daytime for 30 days prior to onset of varicella or zoster case.

Tipo de datos

integer

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

Varicella or zoster index case

Alias
UMLS CUI-1
C2597943
UMLS CUI-2
C0008049
UMLS CUI-4
C2597943
UMLS CUI-5
C0740380
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?
Descripción

Varicella or zoster index case

Tipo de datos

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
Descripción

Type of contact

Tipo de datos

integer

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

Frequency of contact

Tipo de datos

integer

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

Only answer if you choose "occasional contact"

Tipo de datos

date

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

Nature of contact

Tipo de datos

integer

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

Specify other kind of contact

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392367
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Confirmation of index case
Descripción

Confirmation of index case

Alias
UMLS CUI-1
C2597943
UMLS CUI-2
C0521091
Local laboratory confirmed
Descripción

Local laboratory confirmed index case

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011911
UMLS CUI [1,2]
C2597943
Diagnosis by a physician (whenever the physician's diagnosis of the index case is retrievable by the investigator)
Descripción

Diagnosis of index case by a physician

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0031831
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)
Descripción

Index case confirmed at part of a school / day care center / institutional outbreak

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0036375
UMLS CUI [2,1]
C2597943
UMLS CUI [2,2]
C0008070
UMLS CUI [3,1]
C2597943
UMLS CUI [3,2]
C0012652
UMLS CUI [3,3]
C1272753
Diagnosis by investigator
Descripción

Diagnosis of index case by investigator

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0035173
By index-case parents
Descripción

Confirmed by index-case parents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0750484
Not confirmed
Descripción

Index case not confirmed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0521092
Not confirmed
Descripción

Index case not confirmed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2597943
UMLS CUI [1,2]
C0521092
Biological sample
Descripción

Biological sample

Alias
UMLS CUI-1
C2347026
UMLS CUI-2
C0042338
Have biological samples been taken?
Descripción

If yes, please complete the following table.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347026
UMLS CUI [1,2]
C0042338
Biological sample
Descripción

Biological sample

Alias
UMLS CUI-1
C2347026
UMLS CUI-2
C0042338
Date
Descripción

Date sample has been taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347026
UMLS CUI [1,2]
C0011008
Sequential Number
Descripción

Sequential Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1705294
Type
Descripción

Type of biological sample

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2347026
UMLS CUI [1,2]
C0332307
Last 4 digits of Label Code Bar
Descripción

Last 4 digits of Label Code Bar

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C3241971
Rash
Descripción

Rash

Alias
UMLS CUI-1
C0015230
Date rash onset
Descripción

date when first lesion appears

Tipo de datos

date

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

date of first day when no new lesions appear

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
Lesion - Intensity
Descripción

Lesion - Intensity

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C0234687
Day
Descripción

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

Tipo de datos

integer

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

Daily number of overall Lesions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0332173
Vesicles - Intensity
Descripción

Vesicles - Intensity

Alias
UMLS CUI-1
C0333262
UMLS CUI-2
C0234687
Day
Descripción

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

Tipo de datos

text

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

Daily number of overall Vesicles

Tipo de datos

integer

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

Temperature

Alias
UMLS CUI-1
C0039476
Route
Descripción

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

Tipo de datos

text

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

Temperature

Alias
UMLS CUI-1
C0039476
Day
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0039476
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • degree Celsius
Alias
UMLS CUI [1]
C0039476
degree Celsius
Not taken
Descripción

Temperature not taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039476
Date varicella or zoster end
Descripción

Date varicella or zoster end

Alias
UMLS CUI-1
C0008049
UMLS CUI-2
C0806020
UMLS CUI-4
C0740380
UMLS CUI-5
C0806020
Date varicella or zoster end
Descripción

date when subject resumes normal everyday activities.

Tipo de datos

date

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

Health economics

Alias
UMLS CUI-1
C0013556
UMLS CUI-2
C0018684
Did the parents/guardians or family members lose time from work as a result of taking care of the subject during this illness?
Descripción

work time lost due to care taking

Tipo de datos

boolean

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

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 ?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0030551
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 ?
Descripción

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

Tipo de datos

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?
Descripción

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?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0008059
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 ?
Descripción

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

Tipo de datos

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?
Descripción

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?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0085537
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 ?
Descripción

Parents seeking medical advice for illness

Tipo de datos

boolean

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

Pain

Alias
UMLS CUI-1
C0030193
Did the subject present any back or abdominal pain during this varicella or zoster case ?
Descripción

back or abdominal pain varicella or zoster

Tipo de datos

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
Complications
Descripción

Complications

Alias
UMLS CUI-1
C0009566
Any complications as listed in the Protocol ?
Descripción

complications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009566
Serious adverse event (complete the Serious Adverse Event form)
Descripción

Only answer, if you answered previous question with 'yes'. Note: The diagnosis of varicella / zoster should be reported together with the complication as SAE

Tipo de datos

boolean

Please specify SAE No:
Descripción

Number of serious adverse events

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Treatment
Descripción

Treatment

Alias
UMLS CUI-1
C0087111
Was any treatment given for the varicella or zoster case ?
Descripción

If you choose 'yes' please specify in Medication section.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0008049
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0740380
Outcome
Descripción

Outcome

Alias
UMLS CUI-1
C1547647
Outcome
Descripción

Outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1547647
Specify sequelae
Descripción

Only answer this question if you chose before'4 = Recovered with sequelae / resolved with sequelae'.

Tipo de datos

text

Alias
UMLS CUI [1]
C0243088
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Similar models

Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Varicella or zoster case
C0008049 (UMLS CUI-1)
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])
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])
Date of investigator visit
Item
Date of investigator visit
date
C1512346 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Description
integer
C0517733 (UMLS CUI [1])
Description
Code List
Description
CL Item
Varicella (1)
CL Item
Zoster (2)
Macular varicella
Item
Macular Type
boolean
C0008049 (UMLS CUI [1,1])
C0221201 (UMLS CUI [1,2])
Papular Varicella
Item
Papular Type
boolean
C0008049 (UMLS CUI [1,1])
C1519353 (UMLS CUI [1,2])
vesicular varicella
Item
Mostly vesicular type
boolean
C0008049 (UMLS CUI [1,1])
C0221203 (UMLS CUI [1,2])
Hemorrhagic varicella
Item
Hemorrhagic type
boolean
C0008049 (UMLS CUI [1,1])
C0235498 (UMLS CUI [1,2])
Item Group
Intensity - Lesions and vesicles
C0008049 (UMLS CUI-1)
C0234687 (UMLS CUI-2)
Date lesions are examined
Item
Date
date
C0221198 (UMLS CUI [1,1])
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])
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
Daily number of overall vesicles
integer
C3814530 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Daily number of overall vesicles
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
Subjective assessment of the illness by investigator
C0221423 (UMLS CUI-1)
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])
Subjective assessment of the illness by investigator
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)
Item Group
Photographs
C0441468 (UMLS CUI-1)
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])
how many photographs
Item
How many photographs have been taken?
integer
C0441468 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
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 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])
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
Confirmation of index case
C2597943 (UMLS CUI-1)
C0521091 (UMLS CUI-2)
Local laboratory confirmed index case
Item
Local laboratory confirmed
boolean
C0011911 (UMLS CUI [1,1])
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])
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])
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])
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])
Index case not confirmed
Item
Not confirmed
boolean
C2597943 (UMLS CUI [1,1])
C0521092 (UMLS CUI [1,2])
Index case not confirmed
Item
Not confirmed
boolean
C2597943 (UMLS CUI [1,1])
C0521092 (UMLS CUI [1,2])
Item Group
Biological sample
C2347026 (UMLS CUI-1)
C0042338 (UMLS CUI-2)
Biological sample varicella
Item
Have biological samples been taken?
boolean
C2347026 (UMLS CUI [1,1])
C0042338 (UMLS CUI [1,2])
Item Group
Biological sample
C2347026 (UMLS CUI-1)
C0042338 (UMLS CUI-2)
Date sample has been taken
Item
Date
date
C2347026 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sequential Number
Item
Sequential Number
integer
C0237753 (UMLS CUI [1,1])
C1705294 (UMLS CUI [1,2])
Item
Type
integer
C2347026 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of biological sample
Code List
Type
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])
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 - Intensity
C0221198 (UMLS CUI-1)
C0234687 (UMLS CUI-2)
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 - Intensity
C0333262 (UMLS CUI-1)
C0234687 (UMLS CUI-2)
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])
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)
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])
Item Group
Health economics
C0013556 (UMLS CUI-1)
C0018684 (UMLS CUI-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])
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 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])
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 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])
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 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])
Item Group
Pain
C0030193 (UMLS CUI-1)
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])
Item Group
Complications
C0009566 (UMLS CUI-1)
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])
Item Group
Treatment
C0087111 (UMLS CUI-1)
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])
Item Group
Outcome
C1547647 (UMLS CUI-1)
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered / resolved (1)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Specify sequelae
Item
Specify sequelae
text
C0243088 (UMLS CUI [1])
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