ID

36261

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-04-25 2019-04-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172

Engelsk

Non-Serious Adverse Events

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 31 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beskrivning

Non-serious Adverse Event, Administration of vaccine, Post

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
AE No.
Beskrivning

Non-serious Adverse Event, Numbers

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Beskrivning

Non-serious Adverse Event, Description

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Date Started
Beskrivning

Non-serious Adverse Event, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Date Stopped
Beskrivning

Non-serious Adverse Event, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Intensity
Beskrivning

Non-serious Adverse Event, Severity of Adverse Event

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Non-serious Adverse Event, Relationships, Experimental drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Beskrivning

Non-serious Adverse Event, Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit (Refer to protocol for full definition.)
Beskrivning

Non-serious Adverse Event, Visit, Advice, Medical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beskrivning

Non-serious Adverse Event, Visit, Advice, Medical, Type

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
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Similar models

Non-Serious Adverse Events

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, Administration of vaccine, Post
Item
Has any non-serious adverse events occurred within one month (minimum 31 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serios Adverse Event, Numbers
Code List
AE No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, End Date
Item
Date Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-serious Adverse Event, Relationships, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event 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)
Non-serious Adverse Event, Visit, Advice, Medical
Item
Medically attended visit (Refer to protocol for full definition.)
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-serious Adverse Event, Visit, Advice, Medical, Type
Item
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
text
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
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