ID

29493

Descrição

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

Palavras-chave

Versões (2)
  1. 31/03/2018 31/03/2018 -
  2. 04/04/2018 04/04/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

4 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Inglês

Study Conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study Conclusion
Header
Descrição

Header

Alias
UMLS CUI-1
C1320722
Subject No.
Descrição

Subject No.

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Occurrence of serious adverse event
Descrição

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
Descrição

Serious adverse event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE's
Descrição

Only answer if you chose 'yes'a s previous answer.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Status of treatment blind
Descrição

Status of treatment blind

Was the treatment blind broken during the study?
Descrição

If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
If treatment blind was broken, complete the following: Date blind broken
Descrição

Date blind broken

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If treatment blind was broken, complete the following: Reason blind broken
Descrição

Reason blind broken

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Specify if other
Descrição

Reason blind broken - other

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Elimination criteria
Descrição

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study?
Descrição

Elimination criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
Please specify elimination criteria.
Descrição

specify elimination criteria

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Study Withdrawal
Descrição

Study Withdrawal

Alias
UMLS CUI-1
C2348568
Was the subject withdrawn from study?
Descrição

withdrawn

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate category for drop out
Descrição

If Yes, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
SAE Number
Descrição

If Serious adverse event, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descrição

If Non-serious adverse event, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If Protocol violation, please specify
Descrição

Protocol violation

Tipo de dados

text

Alias
UMLS CUI [1]
C1709750
Other reason for withdrawal
Descrição

If Other, please specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
reason for withdrawal, Who made the decision?
Descrição

reason for withdrawal

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of last contact
Descrição

Date of last contact

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Was the subject in good condition at date of last contact?
Descrição

subject condition

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigators signature
Descrição

Investigators signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Descrição

Investigators signature Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
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Similar models

Study Conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
boolean
C1519255 (UMLS CUI [1])
number of serious adverse events
Item
Specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Status of treatment blind
treatment blind broken during the study
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date blind broken
Item
If treatment blind was broken, complete the following: Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If treatment blind was broken, complete the following: Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
If treatment blind was broken, complete the following: Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Reason blind broken - other
Item
Specify if other
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
specify elimination criteria
Item
Please specify elimination criteria.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Study Withdrawal
C2348568 (UMLS CUI-1)
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for drop out
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
Please tick the ONE most appropriate category for drop out
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Protocol violation
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for withdrawal, Who made the decision?
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
reason for withdrawal, Who made the decision?
CL Item
Investigator’s decision (1)
CL Item
Parents/Guardian’s decision (2)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section (1)
CL Item
Yes (2)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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