ID

35889

Description

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Keywords

Versions (1)
  1. 4/2/19 4/2/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 2, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

English

Rash / Exanthema

1 forms  
  1. StudyEvent: ODM
    1. Rash / Exanthema
Administrative Data
Description

Administrative Data

Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Rash / Exanthema
Description

Rash / Exanthema

Alias
UMLS CUI-1
C0015230
Rash No.
Description

Exanthema, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
Description
Description

Exanthema, Description

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0678257
Description
Description

Exanthema, Description

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0678257
If Localized, Localisation
Description

Exanthema, Localisation

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0475264
If Administrazion site, Vaccine
Description

Exanthema, Administration of Vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C2368628
Category
Description

Exanthema, Category

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0683312
Date started
Description

Exanthema, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Date stopped
Description

Exanthema, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
Intensity
Description

Exanthema, Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0518690
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Exanthema, Relationship, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Description

Exanthema, Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C1547647
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Description

Exanthema, Visit, advice, medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Description

Exanthema, Visit, advice, medical, Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
Back to the top of the page

Similar models

Rash / Exanthema

1 forms
  1. StudyEvent: ODM
    1. Rash / Exanthema
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Rash / Exanthema
C0015230 (UMLS CUI-1)
Item
Rash No.
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Exanthema, Numbers
Code List
Rash No.
CL Item
RA.1 (1)
CL Item
RA.2 (2)
Exanthema, Description
Item
Description
text
C0015230 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Description
text
C0015230 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Exanthema, Description
Code List
Description
CL Item
Generalized (1)
CL Item
Localized (2)
Item
If Localized, Localisation
text
C0015230 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Exanthema, Description
Code List
If Localized, Localisation
CL Item
Administration site (1)
CL Item
Other location : specify : (2)
Item
If Administrazion site, Vaccine
text
C0015230 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Exanthema, Description
Code List
If Administrazion site, Vaccine
CL Item
Hib-MenCY-TTvaccine (1)
CL Item
DM-M-R®II vaccine  (2)
CL Item
D Varivax® vaccine (3)
CL Item
D PedvaxHIB® vaccine (4)
Item
Category
text
C0015230 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Exanthema, Category
Code List
Category
CL Item
Varicella rash (1)
CL Item
Measles / rubella-rash (2)
CL Item
Other (3)
Exanthema, Start Date
Item
Date started
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Exanthema, End Date
Item
Date stopped
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C0015230 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Exanthema, Intensity
Code List
Intensity
CL Item
1–10lesions (1)
CL Item
11 – 30 lesions  (2)
CL Item
31 – 100 lesions  (3)
CL Item
101 – 200 lesions  (4)
CL Item
>200lesions (5)
Exanthema, Relationship, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0015230 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C0015230 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Exanthema, 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)
Exanthema, Visit, advice, medical
Item
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C0015230 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Exanthema, Visit, advice, medical, Type
Item
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C0015230 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial