ID

35891

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

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

English

Febrile Convulsions - Suspected Signs of Meningitis Events

1 forms  
Administrative Data
Description

Administrative Data

Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Febrile Convulsions - Suspected Signs of Meningitis Events
Description

Febrile Convulsions - Suspected Signs of Meningitis Events

Alias
UMLS CUI-1
C0009952
UMLS CUI-2
C0025287
FC No.
Description

Febrile Convulsions, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0237753
Description
Description

Febrile Convulsions, Description

Data type

text

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0678257
Date started
Description

Febrile Convulsions, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0808070
Date stopped
Description

Febrile Convulsions, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0806020
Intensity
Description

Febrile Convulsions, Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0518690
Was a neurological examination performed?
Description

Febrile Convulsions, Neurologic Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0027853
if yes, was a lumbar puncture performed?
Description

if yes, please send a copy of Medical Report

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0037943
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Febrile Convulsions, Relationship, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Description

Febrile Convulsions, Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0009952
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

Febrile Convulsions, Visit, advice, medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Description

Febrile Convulsions, Visit, advice, medical, Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
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Similar models

Febrile Convulsions - Suspected Signs of Meningitis Events

1 forms
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
Febrile Convulsions - Suspected Signs of Meningitis Events
C0009952 (UMLS CUI-1)
C0025287 (UMLS CUI-2)
Item
FC No.
text
C0009952 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Exanthema, Numbers
Code List
FC No.
CL Item
FC.1 (1)
CL Item
FC.2 (2)
Febrile Convulsions, Description
Item
Description
text
C0009952 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Febrile Convulsions, Start Date
Item
Date started
date
C0009952 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Febrile Convulsions, End Date
Item
Date stopped
date
C0009952 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C0009952 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Exanthema, Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Febrile Convulsions, Neurologic Examination
Item
Was a neurological examination performed?
boolean
C0009952 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Febrile Convulsions, Spinal Puncture
Item
if yes, was a lumbar puncture performed?
boolean
C0009952 (UMLS CUI [1,1])
C0037943 (UMLS CUI [1,2])
Febrile Convulsions, 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
C0009952 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C0009952 (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)
Febrile Convulsions, 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
C0009952 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Febrile Convulsions, Visit, advice, medical, Type
Item
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C0009952 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
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