ID
25186
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-08-28 2017-08-28 -
Rättsinnehavare
glaxoSmithKline
Uppladdad den
28 augusti 2017
DOI
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Licens
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
Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499
Beskrivning
Lesion
Alias
- UMLS CUI-1
- C0221198
Beskrivning
Day 0-14 Day 0 should be date rash onset - Complete until date rash end
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0221198
Beskrivning
Daily number of overall Lesions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0332173
Beskrivning
Vesicles
Alias
- UMLS CUI-1
- C0333262
Beskrivning
Day 0 should be date rash onset - Complete until date rash end
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0333262
Beskrivning
Estimation of the DAILY number of vesicles (=lesions with fluid in them) according to the following ranges
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0333262
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0332173
Beskrivning
Temperature
Alias
- UMLS CUI-1
- C0039476
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1515974
Beskrivning
Temperature
Alias
- UMLS CUI-1
- C0039476
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0039476
Beskrivning
Date Temperature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0011008
Beskrivning
Temperature
Datatyp
float
Måttenheter
- degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Temperature not taken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Weekdays location
Alias
- UMLS CUI-1
- C0450429
- UMLS CUI-2
- C0680189
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008070
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008070
- UMLS CUI [1,2]
- C0439603
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0442519
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0442519
- UMLS CUI [1,2]
- C0439603
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0036375
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0036375
- UMLS CUI [1,2]
- C0439603
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0730005
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0730005
- UMLS CUI [1,2]
- C0439603
Beskrivning
Number of children at childminder
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0730005
- UMLS CUI [1,2]
- C0008059
- UMLS CUI [1,3]
- C0449788
Beskrivning
at childminder
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008059
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0455469
Beskrivning
Number of children with negative varicella history unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008059
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0455469
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0205394
Beskrivning
Record whereabouts of your child during daytime for 30 days prior to onset of varicella (chickenpox) rash or zoster case (shingles).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0439603
Beskrivning
Varicella or zoster index case
Alias
- UMLS CUI-1
- C2597943
- UMLS CUI-2
- C0008049
- UMLS CUI-4
- C2597943
- UMLS CUI-5
- C0740380
Beskrivning
Varicella or zoster index case
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2597943
- UMLS CUI [1,2]
- C0008049
- UMLS CUI [2,1]
- C2597943
- UMLS CUI [2,2]
- C0740380
Beskrivning
Type of contact
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332158
- UMLS CUI [1,2]
- C0332307
Beskrivning
Frequency of contact
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008049
- UMLS CUI [1,2]
- C0332158
- UMLS CUI [1,3]
- C0439603
Beskrivning
Only answer if you choose "occasional contact"
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332158
- UMLS CUI [1,3]
- C0008049
Beskrivning
Nature of contact
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0392367
- UMLS CUI [1,2]
- C0332307
Beskrivning
Specify other kind of contact
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392367
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
Date varicella or zoster end
Alias
- UMLS CUI-1
- C0008049
- UMLS CUI-2
- C0806020
- UMLS CUI-4
- C0740380
- UMLS CUI-5
- C0806020
Beskrivning
Health economics
Alias
- UMLS CUI-1
- C0013556
- UMLS CUI-2
- C0018684
Beskrivning
work time lost due to care taking
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0237107
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0585074
Beskrivning
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 ?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439227
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [1,3]
- C0030551
Beskrivning
time lost at day care / childminder / school attendance / extracurricular activity
Datatyp
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
Beskrivning
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?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439227
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [1,3]
- C0008059
Beskrivning
Assistance needed by nurse, babysitter or any type of paid caregiver
Datatyp
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
Beskrivning
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?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439227
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [1,3]
- C0085537
Beskrivning
Parents seeking medical advice for illness
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1386497
- UMLS CUI [1,2]
- C0030551
- UMLS CUI [1,3]
- C2348568
Beskrivning
Pain
Alias
- UMLS CUI-1
- C0030193
Similar models
Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499
C0574845 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0333262 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0455469 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0008049 (UMLS CUI-2)
C2597943 (UMLS CUI-4)
C0740380 (UMLS CUI-5)
C0008049 (UMLS CUI [1,2])
C2597943 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
C0332158 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0332158 (UMLS CUI [1,2])
C0008049 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0806020 (UMLS CUI-2)
C0740380 (UMLS CUI-4)
C0806020 (UMLS CUI-5)
C0806020 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0012634 (UMLS CUI [1,2])
C0585074 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
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])
C1265611 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
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])
C1265611 (UMLS CUI [1,2])
C0085537 (UMLS CUI [1,3])
C0030551 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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])
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