ID

36259

Description

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

Mots-clés

  1. 25/04/2019 25/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 avril 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172

  1. StudyEvent: ODM
    1. Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Medication
Description

Medication

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

If Yes, please complete the following table.

Type de données

boolean

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

Pharmaceutical Preparations, Medication name

Type de données

text

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

Pharmaceutical Preparations, Indication

Type de données

text

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

Pharmaceutical Preparations, Daily Dose, Total

Type de données

text

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

Pharmaceutical Preparations, Drug Administration Routes

Type de données

text

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

Pharmaceutical Preparations, Start Date

Type de données

date

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

Pharmaceutical Preparations, End Date

Type de données

date

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

Pharmaceutical Preparations, Continuous

Type de données

boolean

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

Similar models

Medication

  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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