ID

36259

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

  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

Medication

  1. StudyEvent: ODM
    1. Medication
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
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Beskrivning

If Yes, please complete the following table.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2603343
Trade / Generic Name
Beskrivning

Pharmaceutical Preparations, Medication name

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Medical Indication
Beskrivning

Pharmaceutical Preparations, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Beskrivning

Pharmaceutical Preparations, Daily Dose, Total

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route
Beskrivning

Pharmaceutical Preparations, Drug Administration Routes

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Beskrivning

Pharmaceutical Preparations, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beskrivning

Pharmaceutical Preparations, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Beskrivning

Pharmaceutical Preparations, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178

Similar models

Medication

  1. StudyEvent: ODM
    1. Medication
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
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations, During, Study
Item
Have any medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medication name
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Tick box if continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

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