ID

29494

Descripción

A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

Palabras clave

Versiones (2)
  1. 31/3/18 31/3/18 -
  2. 4/4/18 4/4/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de abril de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Inglés

Visit 3

1 formularios  
  1. StudyEvent: ODM
    1. Visit 3
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Subject No.
Descripción

Subject No.

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Descripción

DD/MON/YY

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Check for Study Continuation
Descripción

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 3?
Descripción

subject return for visit 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Same reason as previous visit
Descripción

Or fill out below

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descripción

If No, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Descripción

If Serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descripción

If Non-serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Descripción

If Other, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Descripción

reason for study discontinuation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Please tick who took decision:
Descripción

Decision

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Blood sample
Descripción

Blood sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken?
Descripción

Has a blood sample been taken?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Descripción

Please complete only if different from visit date:

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Gastroenteritis Episodes
Descripción

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Did the subject present Gastroenteritis anytime starting from 8 days after dose 1 until Dose 2?
Descripción

If Yes, please fill the Gastroenteritis section. please collect a stool sample as soon as possible after Gastroenteritis begins and not later than 7 days after the start of the Gastroenteritis and report the stool collection date in the Gastroenteritis section.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017160
Height / Weight
Descripción

Height / Weight

Height
Descripción

Patient Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI [1]
C0489786
cm
Weight
Descripción

Patient Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
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Similar models

Visit 3

1 formularios
  1. StudyEvent: ODM
    1. Visit 3
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 3?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject come at visit 3?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Same reason for discontinuation
Item
Same reason as previous visit
boolean
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Non-Serious adverse Event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
non administration
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision
Code List
Please tick who took decision:
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Blood sample
C0005834 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from 8 days after dose 1 until Dose 2?
boolean
C0017160 (UMLS CUI [1])
Item Group
Height / Weight
Patient Height
Item
Height
integer
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS CUI [1])
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
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