ID

29762

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Non-serious adverse events and study conclusion Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

Englisch

Non-serious adverse events and study conclusion

1 Formulare  
Non-serious adverse events
Beschreibung

Non-serious adverse events

Alias
UMLS CUI-1
C1518404
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). Has any non-serious adverse events occurred within one month (minimum 30 days) post vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

Non-serious adverse events

Datentyp

text

Alias
UMLS CUI [1]
C1518404
AE No.
Beschreibung

AE No.

Datentyp

integer

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

Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1518404
Date Started
Beschreibung

Date Started

Datentyp

date

Alias
UMLS CUI [1]
C2697888
During immediate post-vaccination period (60 minutes)?
Beschreibung

Adverse event start

Datentyp

boolean

Alias
UMLS CUI [1]
C2697888
Date stopped
Beschreibung

Date stopped

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome (at the interim analysis timepoint)
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Study conclusion
Beschreibung

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject experience any Serious Adverse Event during the study period?
Beschreibung

Serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
If you answered the previous question with Yes → Specify total number of SAE's:
Beschreibung

Total number of SAE's

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Was the treatment blind broken during the study?
Beschreibung

Treatment blind

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
If you answered the previous question with Yes → Complete date and tick one reason below.
Beschreibung

Treatment blind broken date

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If you answered the previous question with Yes Complete date and tick one reason below.
Beschreibung

Treatment blind broken reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Did any elimination criteria become applicable during the study?
Beschreibung

Elimination criteria

Datentyp

integer

Was the subject withdrawn from the study?
Beschreibung

Subject withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
Beschreibung

Withdrawal reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Please tick who took decision:
Beschreibung

Decision maker

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact:
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschreibung

Condition at date of last contact

Datentyp

text

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C1142435
UMLS CUI [1,3]
C0681850
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschreibung

Investigators signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschreibung

Investigator signature date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name:
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Non-serious adverse events and study conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-serious adverse events
C1518404 (UMLS CUI-1)
Item
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). Has any non-serious adverse events occurred within one month (minimum 30 days) post vaccination, excluding those recorded on the Solicited Adverse Events pages?
text
C1518404 (UMLS CUI [1])
Non-serious adverse events
Code List
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). Has any non-serious adverse events occurred within one month (minimum 30 days) post vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (No)
CL Item
Yes, please complete the following table. (Yes, please complete the following table.)
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Site
Code List
Site
CL Item
[L] Administration site ([L] Administration site)
CL Item
[G] Non-administration site ([G] Non-administration site)
Date Started
Item
Date Started
date
C2697888 (UMLS CUI [1])
Adverse event start
Item
During immediate post-vaccination period (60 minutes)?
boolean
C2697888 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2697886 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
Relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome (at the interim analysis timepoint)
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome (at the interim analysis timepoint)
CL Item
[1] Recovered / Resolved (1)
CL Item
[2] Recovering / resolving (2)
CL Item
[3] Not recovered / not resolved (3)
CL Item
[4] Recovered with sequelae / Resolved with sequelae (4)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of SAE's
Item
If you answered the previous question with Yes → Specify total number of SAE's:
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Treatment blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Treatment blind broken date
Item
If you answered the previous question with Yes → Complete date and tick one reason below.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If you answered the previous question with Yes Complete date and tick one reason below.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Treatment blind broken reason
Code List
If you answered the previous question with Yes Complete date and tick one reason below.
CL Item
[1] Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
[2] Other, specify: _______________________________________________ (2)
Item
Did any elimination criteria become applicable during the study?
integer
Elimination criteria
Code List
Did any elimination criteria become applicable during the study?
CL Item
No (1)
CL Item
Yes → Specify: __________________________________________________________ (2)
Subject withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal reason
Code List
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
CL Item
[SAE] Serious adverse event (check Serious Adverse Event form) Please specify SAE N°: |__|__| (1)
CL Item
[AEX] Non-Serious adverse event (check the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| (2)
CL Item
[PTV] Protocol violation, please specify: _______________________________________ (3)
CL Item
[CWS] Consent withdrawal, not due to an adverse event. (4)
CL Item
[MIG] Migrated / moved from the study area (5)
CL Item
[LFU] Lost to follow-up. (6)
CL Item
[OTH] Other, please specify: _________________________________________________ (7)
Item
Please tick who took decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision maker
Code List
Please tick who took decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Condition at date of last contact
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (No, please give details within the Adverse Events section.)
CL Item
Yes (Yes)
Investigators signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
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