ID

29703

Description

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

Keywords

Versions (1)
  1. 4/13/18 4/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

German English

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

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Gastroenteritis Episodes
Description

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Gastroenteritis Episode
Description

Gastroenteritis Episode

Data type

integer

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

Medical advice

Data type

boolean

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

Type - Medical advice

Data type

integer

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

Stool collection time

Data type

datetime

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

Stool collection time

Data type

datetime

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

Medication for diarrhea

Data type

text

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

Gastroenteritis protocol

Alias
UMLS CUI-1
C0017160
date of gastroenteritis episode
Description

date of gastroenteritis episode

Data type

date

Alias
UMLS CUI [1]
C0011008
loose stool count
Description

loose stool count

Data type

integer

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

vomiting count

Data type

integer

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

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken
Description

Temperature not taken

Data type

boolean

Alias
UMLS CUI [1]
C0039476
Concomitant Vaccination
Description

Concomitant Vaccination

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

Concomitant vaccination

Data type

boolean

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

Concomitant Vaccination

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

Name

Data type

text

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

Route

Data type

text

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

Administration date

Data type

date

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

Aktuelle Medikation

Medication
Description

Medication

Data type

integer

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

Medication

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

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
Indication
Description

Indication

Data type

text

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

Prophylactic

Data type

boolean

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

Total daily dose

Data type

text

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

Administration Route

Data type

text

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

Medication Start Date

Data type

date

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

Medication End Date

Data type

date

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

Medication Ongoing

Data type

boolean

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

Non-serious Adverse Events

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

non-serious adverse events

Data type

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Description

Adverse Event Number

Data type

integer

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

Description

Data type

text

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

Description

Data type

integer

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

Type of vaccine

Data type

integer

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

Start Date

Data type

date

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

Start

Data type

boolean

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

End Date

Data type

date

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

Maximum Intensity

Data type

integer

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

Relationship to investigational product(s)

Data type

boolean

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

Outcome

Data type

text

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

Medically attended visit

Data type

boolean

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

Medically attended visit type

Data type

text

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

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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