ID

25215

Beschreibung

Adverse Experiences - Continued form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

Versionen (1)
  1. 28.08.17 28.08.17 -
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GlaxoSmithKline

Hochgeladen am

28. August 2017

DOI

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Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125

Englisch

Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125

1 Formulare  
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beschreibung

Protocol

Datentyp

text

Alias
UMLS CUI [1]
C1507394
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Adverse Experiences
Beschreibung

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Has any adverse experience occurred since the first study vaccine administration in addition to those recorded on the Solicited Adverse Experience forms ?
Beschreibung

if Yes, please complete below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C0877248
Experience
Beschreibung

Experience

Alias
UMLS CUI-1
C0877248
AE
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Local (injection site)
Beschreibung

Local reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853813
UMLS CUI [1,2]
C2700396
General
Beschreibung

General reaction

Datentyp

boolean

Alias
UMLS CUI [1]
C1710276
Date Started
Beschreibung

day/month/year

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Time of onset (if applicable)
Beschreibung

hours/minutes if the experience is observed during the immediate post vaccination period specified in the protocol, the exact time of onset has to be specified

Datentyp

time

Alias
UMLS CUI [1]
C0449244
Date stopped
Beschreibung

day/month/year

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Duration if less than 24 hours
Beschreibung

hours/minutes

Datentyp

time

Alias
UMLS CUI [1]
C0449238
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Relationship to Study Vaccine
Beschreibung

Relationship to Study Vaccine

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439849
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
continuing at end of study
Beschreibung

continuing at end of study

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
Corrective Therapy
Beschreibung

If yes, record in the Medication Section

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Do you consider this a serious adverse experience?
Beschreibung

If yes, report experience to SB by phone within 24hrs and complete the SAEF form.

Datentyp

boolean

Alias
UMLS CUI [1]
C1547644
SAE number
Beschreibung

For SB

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Beschreibung

day/month/year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Beschreibung

I have assessed all Adverse Experiences and filled in all end dates if appropriate.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Additional adverse experience
Item
Has any adverse experience occurred since the first study vaccine administration in addition to those recorded on the Solicited Adverse Experience forms ?
boolean
C1524062 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Experience
C0877248 (UMLS CUI-1)
Adverse Event
Item
AE
text
C0877248 (UMLS CUI [1])
Local reaction
Item
Local (injection site)
boolean
C0853813 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
General reaction
Item
General
boolean
C1710276 (UMLS CUI [1])
Date started
Item
Date Started
date
C3173309 (UMLS CUI [1])
Time of onset (if applicable)
Item
Time of onset (if applicable)
time
C0449244 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C1531784 (UMLS CUI [1])
Duration
Item
Duration if less than 24 hours
time
C0449238 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Vaccine
text
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Relationship to study
Code List
Relationship to Study Vaccine
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
0ngoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
continuing at end of study
Item
continuing at end of study
boolean
C1553904 (UMLS CUI [1])
Corrective therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Seriousness of adverse event
Item
Do you consider this a serious adverse experience?
boolean
C1547644 (UMLS CUI [1])
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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