ID
28998
Beschreibung
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.
Stichworte
Versionen (1)
- 20.02.18 20.02.18 -
Rechteinhaber
GlaxoSmithKline (GSK)
Hochgeladen am
20. Februar 2018
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518
Diary Card, local and general symptoms
- StudyEvent: ODM
Beschreibung
Redness
Alias
- UMLS CUI-1
- C0332575
- UMLS CUI-2
- C2700396
Beschreibung
Ongoing redness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschreibung
If you answered the previous question with yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschreibung
Medically attended visit concerning redness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Beschreibung
Swelling day and size
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C0456389
- UMLS CUI-3
- C2700396
Beschreibung
Swelling
Alias
- UMLS CUI-1
- C0038999
Beschreibung
Ongoing Swelling
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschreibung
If you answered the previous question with yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Medically attended visit concerning swelling
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0038999
Beschreibung
Pain day and intensity
Alias
- UMLS CUI-1
- C0030193
- UMLS CUI-2
- C0522510
- UMLS CUI-3
- C2700396
Beschreibung
Pain
Alias
- UMLS CUI-1
- C0030193
Beschreibung
Ongoing pain
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beschreibung
If you answered the previous question with yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beschreibung
Medically attended visit concerning pain
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0030193
Beschreibung
Other local symptoms
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschreibung
Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Continuing symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
Temperature day and °C
Alias
- UMLS CUI-1
- C0518690
- UMLS CUI-2
- C0039476
Beschreibung
Temperature
Alias
- UMLS CUI-1
- C0005903
Beschreibung
Ongoing fever
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0549178
Beschreibung
If you answered the previous question with yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Beschreibung
Medically attended visit concerning fever
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beschreibung
Irritability/Fussiness day and intensity
Alias
- UMLS CUI-1
- C0022107
- UMLS CUI-2
- C0522510
Beschreibung
Irritability / Fussiness
Alias
- UMLS CUI-1
- C0022107
Beschreibung
Ongoing Irritability / Fussiness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last Irritability / Fussiness
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0011008
Beschreibung
Medically attended visit concerning Irritability / Fussiness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0022107
Beschreibung
Drowsiness day and intensity
Alias
- UMLS CUI-1
- C0013144
- UMLS CUI-2
- C0522510
Beschreibung
Drowsiness
Alias
- UMLS CUI-1
- C0013144
Beschreibung
Ongoing drowsiness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
Beschreibung
Medically attended visit concerning drowsiness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Beschreibung
Loss of appetite day and intensity
Alias
- UMLS CUI-1
- C1971624
- UMLS CUI-2
- C0522510
Beschreibung
Loss of appetite
Alias
- UMLS CUI-1
- C1971624
Beschreibung
Ongoing loss of appetite
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0011008
Beschreibung
Medically attended visit concerning loss of appetite
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Beschreibung
Other general symptoms
Alias
- UMLS CUI-1
- C0029625
Beschreibung
Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0029625
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0159028
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Continuing general symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0029625
- UMLS CUI [1,2]
- C0549178
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0029625
Beschreibung
Medication
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Please fill in below if any medication has been taken since the vaccination
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beschreibung
Reason
Datentyp
text
Alias
- UMLS CUI [1]
- C0392360
Beschreibung
Total daily dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Continuing medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschreibung
General information Dairy card
Alias
- UMLS CUI-1
- C1508263
Beschreibung
Return of Diary card
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C1548100
Beschreibung
Hospitalisation information
Datentyp
text
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
Hospitalisation information
Datentyp
integer
Alias
- UMLS CUI [1]
- C0019993
Ähnliche Modelle
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])
Keine Kommentare