ID

26183

Beschreibung

Study ID: 101223 Clinical Study ID: 101223 Study Title: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Non-Serious Adverse Events

Stichworte

Versionen (1)
  1. 10.10.17 10.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Oktober 2017

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.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Non-Serious Adverse Events 101223

Englisch

Non-Serious Adverse Events GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulare  
Non-Serious Adverse Event
Beschreibung

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C2240392
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

non-serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Beschreibung

AE No.

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Description:
Beschreibung

Adverse Event Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Adverse Event Description
Beschreibung

Adverse Event Description

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Administration site
Beschreibung

Adverse Event Description

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Date Started:
Beschreibung

Date Started

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
during immediate postvaccination period (30 minutes)
Beschreibung

immediate postvaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231291
UMLS CUI [1,2]
C0877248
Date Stopped:
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity:
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1518404
Outcome:
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit:
Beschreibung

(Refer to protocol for full definition.)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit. If yes please specify type
Beschreibung

Refer to protocol for full definition.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Non-Serious Adverse Events GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
C2240392 (UMLS CUI-2)
non-serious adverse event
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
AE No.
Item
AE No.
integer
C0877248 (UMLS CUI [1])
Adverse Event Description
Item
Description:
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Adverse Event Description
integer
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Adverse Event Description
Code List
Adverse Event Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Administration site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration site
Code List
Administration site
CL Item
DTPw-HBV/Hib Kft vaccine (1)
CL Item
Tritanrix-HepB/Hiberix vaccine (2)
CL Item
Triple Antigen vaccine (3)
CL Item
Hiberix vaccine (4)
Date Started
Item
Date Started:
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
immediate postvaccination
Item
during immediate postvaccination period (30 minutes)
boolean
C0231291 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
End Date
Item
Date Stopped:
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity:
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity:
Code List
Maximum Intensity:
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome:
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome:
Code List
Outcome:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit:
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit. If yes please specify type
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit:
Code List
Medically attended visit. If yes please specify type
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video