ID

24686

Beskrivning

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis This form contains the Non-Serious Adverse Events form

Nyckelord

Versioner (1)
  1. 2017-08-13 2017-08-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 augusti 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B NSAE NCT00290303

Engelsk

GSK non-inferiority of Tritanrix Hepatitis B NSAE NCT00290303

1 Formulär  
Non-Serious Adverse Event
Beskrivning

Non-Serious Adverse Event

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

non-serious adverse event

Datatyp

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Beskrivning

AE No.

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Description:
Beskrivning

Description

Datatyp

text

Alias
UMLS CUI [1]
C0678257
Administration Site
Beskrivning

Administration Site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Non-administration site
Beskrivning

Non-administration site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Date Started:
Beskrivning

Date Started:

Datatyp

date

Alias
UMLS CUI [1]
C0011008
during immediate postvaccination period (30 minutes)
Beskrivning

immediate postvaccination

Datatyp

boolean

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

Date Stopped:

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Maximum Intensity:
Beskrivning

Maximum Intensity:

Datatyp

integer

Alias
UMLS CUI [1]
C0518690
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Relationship to investigational products:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
Outcome:
Beskrivning

Outcome:

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit:
Beskrivning

(Refer to protocol for full definition.)

Datatyp

boolean

Alias
UMLS CUI [1]
C0545082
Medically attended visit. If yes please specify type
Beskrivning

Refer to protocol for full definition.

Datatyp

integer

Alias
UMLS CUI [1]
C0545082
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B NSAE NCT00290303

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
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])
Description
Item
Description:
text
C0678257 (UMLS CUI [1])
Administration Site
Item
Administration Site
boolean
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Non-administration site
Item
Non-administration site
boolean
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date Started:
Item
Date Started:
date
C0011008 (UMLS CUI [1])
immediate postvaccination
Item
during immediate postvaccination period (30 minutes)
boolean
C0231291 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Date Stopped:
Item
Date Stopped:
date
C0011008 (UMLS CUI [1])
Item
Maximum Intensity:
integer
C0518690 (UMLS CUI [1])
Maximum Intensity:
Code List
Maximum Intensity:
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products:
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Item
Outcome:
integer
C1705586 (UMLS CUI [1])
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])
Item
Medically attended visit. If yes please specify type
integer
C0545082 (UMLS CUI [1])
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)
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