ID
28998
Description
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.
Keywords
Versions (1)
- 2/20/18 2/20/18 -
Copyright Holder
GlaxoSmithKline (GSK)
Uploaded on
February 20, 2018
DOI
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License
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
Description
Redness
Alias
- UMLS CUI-1
- C0332575
- UMLS CUI-2
- C2700396
Description
Ongoing redness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Description
If you answered the previous question with yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Description
Medically attended visit concerning redness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Description
Swelling day and size
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C0456389
- UMLS CUI-3
- C2700396
Description
Swelling
Alias
- UMLS CUI-1
- C0038999
Description
Ongoing Swelling
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Description
If you answered the previous question with yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Medically attended visit concerning swelling
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0038999
Description
Pain day and intensity
Alias
- UMLS CUI-1
- C0030193
- UMLS CUI-2
- C0522510
- UMLS CUI-3
- C2700396
Description
Pain
Alias
- UMLS CUI-1
- C0030193
Description
Ongoing pain
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Description
If you answered the previous question with yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Description
Medically attended visit concerning pain
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0030193
Description
Other local symptoms
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Description
Temperature day and °C
Alias
- UMLS CUI-1
- C0518690
- UMLS CUI-2
- C0039476
Description
Temperature
Alias
- UMLS CUI-1
- C0005903
Description
Ongoing fever
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0549178
Description
If you answered the previous question with yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Description
Medically attended visit concerning fever
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Description
Irritability/Fussiness day and intensity
Alias
- UMLS CUI-1
- C0022107
- UMLS CUI-2
- C0522510
Description
Irritability / Fussiness
Alias
- UMLS CUI-1
- C0022107
Description
Ongoing Irritability / Fussiness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0549178
Description
Date of last Irritability / Fussiness
Data type
date
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0011008
Description
Medically attended visit concerning Irritability / Fussiness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0022107
Description
Drowsiness day and intensity
Alias
- UMLS CUI-1
- C0013144
- UMLS CUI-2
- C0522510
Description
Drowsiness
Alias
- UMLS CUI-1
- C0013144
Description
Ongoing drowsiness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0549178
Description
Date of last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
Description
Medically attended visit concerning drowsiness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Description
Loss of appetite day and intensity
Alias
- UMLS CUI-1
- C1971624
- UMLS CUI-2
- C0522510
Description
Loss of appetite
Alias
- UMLS CUI-1
- C1971624
Description
Ongoing loss of appetite
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0549178
Description
Date of last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0011008
Description
Medically attended visit concerning loss of appetite
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Description
Other general symptoms
Alias
- UMLS CUI-1
- C0029625
Description
Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0029625
Description
Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0159028
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing general symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0029625
- UMLS CUI [1,2]
- C0549178
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0029625
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Please fill in below if any medication has been taken since the vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Description
Reason
Data type
text
Alias
- UMLS CUI [1]
- C0392360
Description
Total daily dose
Data type
integer
Alias
- UMLS CUI [1]
- C2348070
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
General information Dairy card
Alias
- UMLS CUI-1
- C1508263
Description
Return of Diary card
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Description
Hospitalisation information
Data type
text
Alias
- UMLS CUI [1]
- C0019993
Description
Hospitalisation information
Data type
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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