ID

25397

Description

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

Keywords

Versions (1)
  1. 9/3/17 9/3/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 3, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
Varicella or zoster case
Description

Varicella or zoster case

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

If yes, please complete below

Data type

boolean

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

Date telephone contact with investigator

Data type

date

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

Date of investigator visit

Data type

date

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

Description

Data type

integer

Alias
UMLS CUI [1]
C0517733
Macular Type
Description

Macular varicella

Data type

boolean

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

Papular Varicella

Data type

boolean

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

vesicular varicella

Data type

boolean

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

Hemorrhagic varicella

Data type

boolean

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

Intensity - Lesions and vesicles

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

Date lesions are examined

Data type

date

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

Daily number of overall lesions

Data type

integer

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

Daily number of overall vesicles

Data type

integer

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

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
Description

Subjective assessment of the illness by investigator

Data type

integer

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

Photographs

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

photographs been taken

Data type

boolean

Alias
UMLS CUI [1]
C0441468
Dates of photographs
Description

Dates of photographs

Data type

text

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

how many photographs

Data type

integer

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

Weekdays location

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

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

Data type

boolean

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

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

Data type

integer

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

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

Data type

boolean

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

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

Data type

integer

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

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

Data type

boolean

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

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

Data type

integer

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

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

Data type

boolean

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

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

Data type

integer

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

Number of children at childminder

Data type

integer

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

at childminder

Data type

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.
Description

Number of children with negative varicella history unknown

Data type

boolean

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

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

Data type

text

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

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

Data type

boolean

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

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

Data type

integer

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

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?
Description

Varicella or zoster index case

Data type

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
Description

Type of contact

Data type

integer

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

Frequency of contact

Data type

integer

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

Only answer if you choose "occasional contact"

Data type

date

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

Nature of contact

Data type

integer

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

Specify other kind of contact

Data type

text

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

Confirmation of index case

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

Local laboratory confirmed index case

Data type

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)
Description

Diagnosis of index case by a physician

Data type

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)
Description

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

Data type

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
Description

Diagnosis of index case by investigator

Data type

boolean

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

Confirmed by index-case parents

Data type

boolean

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

Index case not confirmed

Data type

boolean

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

Biological sample

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

If yes, please complete the following table.

Data type

boolean

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

Biological sample

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

Date sample has been taken

Data type

date

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

Sequential Number

Data type

integer

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

Type of biological sample

Data type

integer

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

Last 4 digits of Label Code Bar

Data type

integer

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

Rash

Alias
UMLS CUI-1
C0015230
Date rash onset
Description

date when first lesion appears

Data type

date

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

date of first day when no new lesions appear

Data type

date

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

Lesion - Intensity

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

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

Data type

integer

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

Daily number of overall Lesions

Data type

integer

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

Vesicles - Intensity

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

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

Data type

text

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

Daily number of overall Vesicles

Data type

integer

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

Temperature

Alias
UMLS CUI-1
C0039476
Route
Description

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

Data type

text

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

Temperature

Alias
UMLS CUI-1
C0039476
Day
Description

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

Data type

integer

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

Temperature

Data type

float

Measurement units
  • degree Celsius
Alias
UMLS CUI [1]
C0039476
degree Celsius
Not taken
Description

Temperature not taken

Data type

boolean

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

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
Description

date when subject resumes normal everyday activities.

Data type

date

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

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?
Description

work time lost due to care taking

Data type

boolean

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

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 ?

Data type

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 ?
Description

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

Data type

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?
Description

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?

Data type

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 ?
Description

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

Data type

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?
Description

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?

Data type

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 ?
Description

Parents seeking medical advice for illness

Data type

boolean

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

Pain

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

back or abdominal pain varicella or zoster

Data type

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
Description

Complications

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

complications

Data type

boolean

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

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

Data type

boolean

Please specify SAE No:
Description

Number of serious adverse events

Data type

integer

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

Treatment

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

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

Data type

boolean

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

Outcome

Alias
UMLS CUI-1
C1547647
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1547647
Specify sequelae
Description

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

Data type

text

Alias
UMLS CUI [1]
C0243088
Back to the top of the page

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
Back to the top of the page 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial