ID
25139
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-08-27 2017-08-27 -
Rättsinnehavare
glaxoSmithKline
Uppladdad den
27 augusti 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
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 [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
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
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0449788
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
Parotid / Salivary gland swelling events (day 0-day 42)
Alias
- UMLS CUI-1
- C0240925
- UMLS CUI-2
- C0240668
Beskrivning
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.)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240668
- UMLS CUI [1,2]
- C0449788
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
Convulsion
Alias
- UMLS CUI-1
- C4048158
Beskrivning
Please provide information on convulsions below. During the visit, physician will ask about more details - e.g. symptoms, description, etc.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C0449788
Beskrivning
Start date and time of febrile convulsion
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826806
Beskrivning
End date and time of febrile convulsion
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C4048158
- UMLS CUI [1,2]
- C2826793
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
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
Medication (day 0 - day 42)
Alias
- UMLS CUI-1
- C0013227
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0592503
- UMLS CUI [1,2]
- C0013227
Beskrivning
Medical indication for medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beskrivning
Total daily dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beskrivning
Start Date of medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date of Medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Medication continuing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination 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])
C0449444 (UMLS CUI [1,2])
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])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0240668 (UMLS CUI-2)
C0449788 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C2826806 (UMLS CUI [1,2])
C2826793 (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])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Inga kommentarer