ID

29246

Beschreibung

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Stichworte

Versionen (1)
  1. 11.03.18 11.03.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. März 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

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

Occurrence of serious adverse event

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

Serious adverse event

Datentyp

boolean

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

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Elimination criteria
Beschreibung

Elimination criteria

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

Elimination criteria

Datentyp

boolean

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

specify elimination criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Was the subject withdrawn from study?
Beschreibung

withdrawn

Datentyp

boolean

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

If Yes, please specify

Datentyp

integer

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

If Serious adverse event, please specify

Datentyp

integer

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

If Non-serious adverse event, please specify

Datentyp

integer

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

Protocol violation

Datentyp

text

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

If Other, please specify

Datentyp

text

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

reason for withdrawal

Datentyp

integer

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

Date of last contact

Datentyp

date

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

subject condition

Datentyp

integer

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

Investigators signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Beschreibung

Investigators signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
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
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 Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
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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