ID

29703

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-04-13 2018-04-13 -
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GlaxoSmithKline

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13 april 2018

DOI

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Rotavirus Vaccine RIX4414 Study NCT00289172

Tysk Engelsk

gastroenteritis, concomitant vaccination, medication and non-serious adverse events

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Gastroenteritis Episodes
Beskrivning

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Gastroenteritis Episode
Beskrivning

Gastroenteritis Episode

Datatyp

integer

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0332189
Medical advice
Beskrivning

Medical advice

Datatyp

boolean

Alias
UMLS CUI [1]
C1386497
Type - Medical advice
Beskrivning

Type - Medical advice

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
Stool collection time
Beskrivning

Stool collection time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Stool collection time
Beskrivning

Stool collection time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Medication for diarrhea
Beskrivning

Medication for diarrhea

Datatyp

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0087111
Gastroenteritis protocol
Beskrivning

Gastroenteritis protocol

Alias
UMLS CUI-1
C0017160
date of gastroenteritis episode
Beskrivning

date of gastroenteritis episode

Datatyp

date

Alias
UMLS CUI [1]
C0011008
loose stool count
Beskrivning

loose stool count

Datatyp

integer

Alias
UMLS CUI [1,1]
C2129214
UMLS CUI [1,2]
C1265611
vomiting count
Beskrivning

vomiting count

Datatyp

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C1265611
Body Temperature
Beskrivning

Body Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken
Beskrivning

Temperature not taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0039476
Concomitant Vaccination
Beskrivning

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Concomitant vaccination
Beskrivning

Concomitant vaccination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination
Beskrivning

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Name
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beskrivning

Administration date

Datatyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Aktuelle Medikation
Beskrivning

Aktuelle Medikation

Medication
Beskrivning

Medication

Datatyp

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Medication name
Beskrivning

Medication name

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Indication
Beskrivning

Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Prophylactic
Beskrivning

Prophylactic

Datatyp

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Total daily dose
Beskrivning

Total daily dose

Datatyp

text

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

Administration Route

Datatyp

text

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

Medication Start Date

Datatyp

date

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

Medication End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing
Beskrivning

Medication Ongoing

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Non-serious Adverse Events
Beskrivning

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
non-serious adverse events
Beskrivning

non-serious adverse events

Datatyp

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Beskrivning

Adverse Event Number

Datatyp

integer

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

Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Description
Beskrivning

Description

Datatyp

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Type of vaccine
Beskrivning

Type of vaccine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0678257
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start
Beskrivning

Start

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Beskrivning

End Date

Datatyp

date

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

Maximum Intensity

Datatyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Relationship to investigational product(s)
Beskrivning

Relationship to investigational product(s)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beskrivning

Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C1518404
Medically attended visit type
Beskrivning

Medically attended visit type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C1518404
Tillbaka till toppen

Similar models

gastroenteritis, concomitant vaccination, medication and non-serious adverse events

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
integer
C2348585 (UMLS CUI [1])
Item Group
C0017160 (UMLS CUI-1)
Gastroenteritis Episode
Item
integer
C0017160 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Medical advice
Item
boolean
C1386497 (UMLS CUI [1])
Item
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Stool collection time
Item
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Stool collection time
Item
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication for diarrhea
Code List
Medication for diarrhea
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
C0017160 (UMLS CUI-1)
date of gastroenteritis episode
Item
date
C0011008 (UMLS CUI [1])
loose stool count
Item
integer
C2129214 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
vomiting count
Item
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Body Temperature
Item
float
C0005903 (UMLS CUI [1])
Temperature not taken
Item
boolean
C0039476 (UMLS CUI [1])
Item Group
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant vaccination
Item
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Name
Item
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
 (ID)
CL Item
 (IH)
CL Item
 (IM)
CL Item
 (IV)
CL Item
 (NA)
CL Item
 (OTH)
CL Item
 (PE)
CL Item
 (PO)
CL Item
 (SC)
CL Item
 (SL)
CL Item
 (TD)
CL Item
 (UNK)
Administration date
Item
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Aktuelle Medikation
Item
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Medication
Code List
Medication
CL Item
 (1)
CL Item
 (2)
Item Group
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Medication name
Item
text
C2360065 (UMLS CUI [1])
Indication
Item
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Administration Route
CL Item
 (EXT)
CL Item
 (ID)
CL Item
 (IH)
CL Item
 (IM)
CL Item
 (IR)
CL Item
 (IT)
CL Item
 (IV)
CL Item
 (NA)
CL Item
 (OTH)
CL Item
 (PE)
CL Item
 (PO)
CL Item
 (PR)
CL Item
 (SC)
CL Item
 (SL)
CL Item
 (TD)
CL Item
 (TO)
CL Item
 (UNK)
CL Item
 (VA)
Medication Start Date
Item
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
boolean
C2826666 (UMLS CUI [1])
Item Group
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Item
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
non-serious adverse events
CL Item
 (1)
CL Item
 (2)
Adverse Event Number
Item
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Description
CL Item
 (1)
CL Item
 (2)
Item
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
undefined item
Code List
Type of vaccine
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Start Date
Item
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Relationship to investigational product(s)
Item
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Medically attended visit
Item
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
Medical advice type
Code List
Medically attended visit type
CL Item
 (HO)
CL Item
 (ER)
CL Item
 (MD)
Tillbaka till toppen 

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