ID
28998
Beschrijving
A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.
Trefwoorden
Versies (1)
- 20-02-18 20-02-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
20 februari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518
Diary Card, local and general symptoms
- StudyEvent: ODM
Beschrijving
Redness
Alias
- UMLS CUI-1
- C0332575
- UMLS CUI-2
- C2700396
Beschrijving
Ongoing redness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschrijving
If you answered the previous question with yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Medically attended visit concerning redness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Beschrijving
Swelling day and size
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C0456389
- UMLS CUI-3
- C2700396
Beschrijving
Swelling
Alias
- UMLS CUI-1
- C0038999
Beschrijving
Ongoing Swelling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschrijving
If you answered the previous question with yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Medically attended visit concerning swelling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0038999
Beschrijving
Pain day and intensity
Alias
- UMLS CUI-1
- C0030193
- UMLS CUI-2
- C0522510
- UMLS CUI-3
- C2700396
Beschrijving
Pain
Alias
- UMLS CUI-1
- C0030193
Beschrijving
Ongoing pain
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschrijving
If you answered the previous question with yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beschrijving
Medically attended visit concerning pain
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0030193
Beschrijving
Other local symptoms
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschrijving
Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Continuing symptoms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschrijving
Temperature day and °C
Alias
- UMLS CUI-1
- C0518690
- UMLS CUI-2
- C0039476
Beschrijving
Temperature
Alias
- UMLS CUI-1
- C0005903
Beschrijving
Ongoing fever
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0549178
Beschrijving
If you answered the previous question with yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Beschrijving
Medically attended visit concerning fever
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beschrijving
Irritability/Fussiness day and intensity
Alias
- UMLS CUI-1
- C0022107
- UMLS CUI-2
- C0522510
Beschrijving
Irritability / Fussiness
Alias
- UMLS CUI-1
- C0022107
Beschrijving
Ongoing Irritability / Fussiness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Irritability / Fussiness
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0011008
Beschrijving
Medically attended visit concerning Irritability / Fussiness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0022107
Beschrijving
Drowsiness day and intensity
Alias
- UMLS CUI-1
- C0013144
- UMLS CUI-2
- C0522510
Beschrijving
Drowsiness
Alias
- UMLS CUI-1
- C0013144
Beschrijving
Ongoing drowsiness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
Beschrijving
Medically attended visit concerning drowsiness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Beschrijving
Loss of appetite day and intensity
Alias
- UMLS CUI-1
- C1971624
- UMLS CUI-2
- C0522510
Beschrijving
Loss of appetite
Alias
- UMLS CUI-1
- C1971624
Beschrijving
Ongoing loss of appetite
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0011008
Beschrijving
Medically attended visit concerning loss of appetite
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Beschrijving
Other general symptoms
Alias
- UMLS CUI-1
- C0029625
Beschrijving
Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0029625
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0159028
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Continuing general symptoms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0029625
- UMLS CUI [1,2]
- C0549178
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0029625
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Please fill in below if any medication has been taken since the vaccination
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beschrijving
Reason
Datatype
text
Alias
- UMLS CUI [1]
- C0392360
Beschrijving
Total daily dose
Datatype
integer
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Continuing medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschrijving
General information Dairy card
Alias
- UMLS CUI-1
- C1508263
Beschrijving
Return of Diary card
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Beschrijving
Hospitalisation information
Datatype
text
Alias
- UMLS CUI [1]
- C0019993
Beschrijving
Hospitalisation information
Datatype
integer
Alias
- UMLS CUI [1]
- C0019993
Similar models
Diary Card, local and general symptoms
- StudyEvent: ODM
C0456389 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0456389 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C0522510 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0039476 (UMLS CUI-2)
C0549178 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0522510 (UMLS CUI-2)
C0439228 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C0522510 (UMLS CUI-2)
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0522510 (UMLS CUI-2)
C1971624 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C0029625 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0029625 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
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