ID
25139
Beschrijving
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
Trefwoorden
Versies (1)
- 27-08-17 27-08-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
27 augustus 2017
DOI
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Licentie
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
Beschrijving
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschrijving
Temperature (day 0-day 14)
Alias
- UMLS CUI-1
- C0039476
Beschrijving
Fever Episode Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Beschrijving
Temperature
Datatype
float
Maateenheden
- degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Medically attended Visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beschrijving
Temperature (day 15-day 42)
Alias
- UMLS CUI-1
- C0039476
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0039476
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Beschrijving
Rash / exanthema (day 0-day 42)
Alias
- UMLS CUI-1
- C0015230
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0449788
Beschrijving
Start Date of rash
Datatype
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date of rash
Datatype
date
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0806020
Beschrijving
Intensity of rash
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0518690
Beschrijving
Parotid / Salivary gland swelling events (day 0-day 42)
Alias
- UMLS CUI-1
- C0240925
- UMLS CUI-2
- C0240668
Beschrijving
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.)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0449788
Beschrijving
Start date of parotid swelling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0808070
Beschrijving
End date of parotid swelling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0806020
Beschrijving
Intensity of parotid swelling
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0518690
Beschrijving
Convulsion
Alias
- UMLS CUI-1
- C4048158
Beschrijving
Please provide information on convulsions below. During the visit, physician will ask about more details - e.g. symptoms, description, etc.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C0449788
Beschrijving
Start date and time of febrile convulsion
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826806
Beschrijving
End date and time of febrile convulsion
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826793
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Unsolicited symptoms (day 0 - day 42)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C4055646
Beschrijving
Description of unsolicited symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0678257
Beschrijving
Intensity of unsolicited symptom
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0234687
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C4055646
Beschrijving
Start date of unsolicited event
Datatype
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0808070
Beschrijving
End Date of unsolicited event
Datatype
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0806020
Beschrijving
Unsolicited symptom continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C4055646
- UMLS CUI [1,3]
- C0549178
Beschrijving
Medication (day 0 - day 42)
Alias
- UMLS CUI-1
- C0013227
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0592503
- UMLS CUI [1,2]
- C0013227
Beschrijving
Medical indication for medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beschrijving
Start Date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date of Medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Medication continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
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