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Informations:
Erreur:
ID
29475
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
Mots-clés
Versions (2)
- 31/03/2018 31/03/2018 -
- 04/04/2018 04/04/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
31 mars 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study 103792
Similar models
Visit 2
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 2 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Non-Serious adverse Event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from 8 days after dose 1 until Dose 2?
boolean
C0017160 (UMLS CUI [1])
CL Item
Breast Milk (1)
CL Item
Infant Formula (2)
CL Item
Both (3)
Date of vaccination
Item
Date
text
C1115436 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item
Regurgitation with in 30 minutes after HRV vaccine or placebo?
text
C0175795 (UMLS CUI [1,1])
C2004489 (UMLS CUI [1,2])
C2004489 (UMLS CUI [1,2])
Code List
Regurgitation with in 30 minutes after HRV vaccine or placebo?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not administered only (NA)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)