ID
25114
Description
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 1 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)
- 8/26/17 8/26/17 -
Copyright Holder
glaxoSmithKline
Uploaded on
August 26, 2017
DOI
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License
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 1
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 1
Description
Unsolicited symptoms (day 0 - day 42)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C4055646
Description
Description of unsolicited symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0678257
Description
Intensity of unsolicited symptom
Data type
integer
Alias
- UMLS CUI [1,1]
- C0234687
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C4055646
Description
Start date of unsolicited event
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0808070
Description
End Date of unsolicited event
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0806020
Description
Unsolicited symptom continuing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0549178
Description
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Description
Fever Episode Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Description
Temperature
Data type
float
Measurement units
- degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Description
Medically attended Visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Description
Temperature (day 15-day 42)
Alias
- UMLS CUI-1
- C0039476
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0039476
Description
Fever
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0039476
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Description
Rash / exanthema (day 0-day 42)
Alias
- UMLS CUI-1
- C0015230
Description
rash number of episode
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0449788
Description
Description of rash
Data type
text
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0678257
Description
Localisation rash
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0475264
Description
Start Date of rash
Data type
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0808070
Description
End Date of rash
Data type
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0806020
Description
Intensity of rash
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0518690
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015230
Description
Parotid / Salivary gland swelling events (day 0-day 42)
Alias
- UMLS CUI-1
- C0240925
- UMLS CUI-2
- C0240668
Description
Parotid Swelling number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0449788
Description
Description of parotid swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0678257
Description
Start date of parotid swelling
Data type
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0808070
Description
End date of parotid swelling
Data type
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0806020
Description
Intensity of parotid swelling
Data type
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0518690
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
Febrile convulsions - Suspected signs of meningism events
Alias
- UMLS CUI-1
- C0009952
- UMLS CUI-2
- C0025287
Description
Febrile convulsion number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0449788
Description
Description of febrile convulsion
Data type
text
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0678257
Description
Start date of febrile convulsion
Data type
date
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0808070
Description
End date of febrile convulsion
Data type
date
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C0806020
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
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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 1
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