ID

23898

Description

Study part: Non- Serious Adverse Events. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/17/17 7/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 17, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Non- Serious Adverse Events Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Non- Serious Adverse Events

1 forms  
NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1518404
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

non-serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Description
Description

Description Non- Serious Adverse Events

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Administration sites
Description

site vaccines

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Non-administration site
Description

site vaccines

Data type

boolean

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

Date Started

Data type

date

Alias
UMLS CUI [1]
C0808070
Date Started-during immediate post-vaccination period (at least 30 minutes)
Description

Date Started

Data type

boolean

Alias
UMLS CUI [1]
C0808070
Date Stopped
Description

Date Stopped

Data type

date

Alias
UMLS CUI [1]
C0806020
Intensity
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

adverse event drug study

Data type

boolean

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

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Did the subject seek medical advice?
Description

medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
If yes please specify type:
Description

medical advice

Data type

integer

Alias
UMLS CUI [1]
C1386497
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Similar models

Non- Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
NON-SERIOUS ADVERSE EVENTS
C1518404 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
non-serious adverse events
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])
Description Non- Serious Adverse Events
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Administration sites
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
site vaccines
Code List
Administration sites
CL Item
Hib-MenCY OR Hib-MenC vaccine [ 9 0 1 ] (1)
CL Item
MenC vaccine [ 9 0 2 ] (2)
CL Item
DTPa-HBV-IPV vaccine [ 1 4 ] (3)
CL Item
DTPa-HBV-IPV/Hib vaccine [ 3 8 ] (4)
site vaccines
Item
Non-administration site
boolean
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date Started
Item
Date Started
date
C0808070 (UMLS CUI [1])
Date Started
Item
Date Started-during immediate post-vaccination period (at least 30 minutes)
boolean
C0808070 (UMLS CUI [1])
Date Stopped
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Item
Intensity
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
adverse event drug study
Item
Relationship to investigational products: 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)
medical advice
Item
Did the subject seek medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
If yes please specify type:
integer
C1386497 (UMLS CUI [1])
medical advice
Code List
If yes please specify type:
CL Item
HO: Hospitalisation (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
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