ID
25139
Descripción
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination 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
Palabras clave
Versiones (1)
- 27/08/2017 27/08/2017 -
Titular de derechos de autor
glaxoSmithKline
Subido en
27 août 2017
DOI
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Licencia
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 - Post Vaccination Dose 2
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2
Descripción
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Descripción
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Descripción
Fever Episode Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Descripción
Temperature
Tipo de datos
float
Unidades de medida
- degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Descripción
Medically attended Visit
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Descripción
Temperature (day 15-day 42)
Alias
- UMLS CUI-1
- C0039476
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0039476
Descripción
Fever
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015967
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0039476
Descripción
Medically attended visit
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Descripción
Rash / exanthema (day 0-day 42)
Alias
- UMLS CUI-1
- C0015230
Descripción
Please provide information on rash/exantem below. During the visit, physician will ask about more details - e.g. its description (size, shape, colour, lay-out, location, itching, soreness, etc.) Do not report here Varicella (Chickenpox) or Zoster (Shingles) here, but report in the Varicella (Chickenpox) or Zoster Case (Shingles) diary card section.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0449788
Descripción
Start Date of rash
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0808070
Descripción
End Date of rash
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0806020
Descripción
Intensity of rash
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0518690
Descripción
Parotid / Salivary gland swelling events (day 0-day 42)
Alias
- UMLS CUI-1
- C0240925
- UMLS CUI-2
- C0240668
Descripción
Please provide information on parotid/salivary gland swelling below. During the visit, physician will ask about more details - e.g. its description (size, reddish skin, soreness, etc.)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0449788
Descripción
Start date of parotid swelling
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0808070
Descripción
End date of parotid swelling
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0806020
Descripción
Intensity of parotid swelling
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0518690
Descripción
Convulsion
Alias
- UMLS CUI-1
- C4048158
Descripción
Please provide information on convulsions below. During the visit, physician will ask about more details - e.g. symptoms, description, etc.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C0449788
Descripción
Start date and time of febrile convulsion
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826806
Descripción
End date and time of febrile convulsion
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826793
Descripción
Fever
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015967
Descripción
Unsolicited symptoms (day 0 - day 42)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C4055646
Descripción
Description of unsolicited symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0678257
Descripción
Intensity of unsolicited symptom
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0234687
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C4055646
Descripción
Start date of unsolicited event
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0808070
Descripción
End Date of unsolicited event
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0806020
Descripción
Unsolicited symptom continuing
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0549178
Descripción
Medication (day 0 - day 42)
Alias
- UMLS CUI-1
- C0013227
Descripción
Please record all medication taken between Day 0 and Day 42 taken after Dose 1 according to the following criteria. All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending 43 days (Day 0 to Day 42) after each dose of study vaccine are to be recorded with name of the medication, reason for taking medication, total daily dose, start and end dates of treatment.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0592503
- UMLS CUI [1,2]
- C0013227
Descripción
Medical indication for medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Descripción
Total daily dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Descripción
Start Date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
End Date of Medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
Medication continuing
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
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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])
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C3146298 (UMLS CUI [1,2])
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