ID
25115
Beskrivning
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2 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)
- 2017-08-26 2017-08-26 -
Rättsinnehavare
glaxoSmithKline
Uppladdad den
26 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2
Beskrivning
Unsolicited symptoms (day 0 - day 42)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C4055646
Beskrivning
Description of unsolicited symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0678257
Beskrivning
Intensity of unsolicited symptom
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0234687
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C4055646
Beskrivning
Start date of unsolicited event
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0808070
Beskrivning
End Date of unsolicited event
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0806020
Beskrivning
Unsolicited symptom continuing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0549178
Beskrivning
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Beskrivning
Please record axillary / rectal temperature daily from day 0 to day 14 after vaccination at bedtime. Only one route of temperature measurement should be used consistently. If temperature has been taken more than once a day, please report the highest value for the day.
Datatyp
text
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Beskrivning
Fever Episode Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Beskrivning
Temperature
Datatyp
float
Måttenheter
- degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Medically attended Visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beskrivning
Temperature (day 15-day 42)
Alias
- UMLS CUI-1
- C0039476
Beskrivning
Day 15-42 Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0039476
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Beskrivning
Rash / exanthema (day 0-day 42)
Alias
- UMLS CUI-1
- C0015230
Beskrivning
rash number of episode
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0449788
Beskrivning
Description of rash
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0678257
Beskrivning
Localisation rash
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0475264
Beskrivning
Start Date of rash
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date of rash
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0806020
Beskrivning
Intensity of rash
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0518690
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015230
Beskrivning
Parotid / Salivary gland swelling events (day 0-day 42)
Alias
- UMLS CUI-1
- C0240925
- UMLS CUI-2
- C0240668
Beskrivning
Parotid Swelling number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0449788
Beskrivning
Description of parotid swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0678257
Beskrivning
Start date of parotid swelling
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0808070
Beskrivning
End date of parotid swelling
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0806020
Beskrivning
Intensity of parotid swelling
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0518690
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Beskrivning
Febrile convulsions - Suspected signs of meningism events
Alias
- UMLS CUI-1
- C0009952
- UMLS CUI-2
- C0025287
Beskrivning
Febrile convulsion number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0449788
Beskrivning
Description of febrile convulsion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0678257
Beskrivning
Start date of febrile convulsion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0808070
Beskrivning
End date of febrile convulsion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0806020
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Similar models
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C4055646 (UMLS CUI-2)
C4055646 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C4055646 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C4055646 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C4055646 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,3])
C0240668 (UMLS CUI-2)
C0449788 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0025287 (UMLS CUI-2)
C0449788 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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