ID

29763

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Monthly field - Worker home visits (for ADI) and absences from study area 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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Lizenz

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

Monthly field - Worker home visits (for ADI) and absences from study area

1 Formulare  
Active surveillance for infection
Beschreibung

Active surveillance for infection

Alias
UMLS CUI-1
C1827061
Field worker visit No.
Beschreibung

Field worker visit No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0237753
Has the child been visited by the field worker?
Beschreibung

Visit performed

Datentyp

boolean

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
History of fever?
Beschreibung

History of fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Axillary temperature:
Beschreibung

Axillary temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C1531924
°C
Blood sample taken for parasite genotyping?
Beschreibung

Parasite genotyping blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0030498
UMLS CUI [1,3]
C1285573
Smear taken?
Beschreibung

Blood smear

Datentyp

boolean

Alias
UMLS CUI [1]
C2238079
Results:
Beschreibung

Blood smear results

Datentyp

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2238079
Absences from study area
Beschreibung

Absences from study area

Alias
UMLS CUI-1
C0348080
UMLS CUI-2
C0332197
UMLS CUI-3
C0681784
Has the subject been absent for more than 2 weeks?
Beschreibung

Absence for more than 2 weeks

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0681784
Approximate date subject left study area
Beschreibung

Date subject left study area

Datentyp

date

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0681784
UMLS CUI [1,3]
C0011008
Approximate date subject returned to study area
Beschreibung

Date subject returned to study area

Datentyp

date

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0681784
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Monthly field - Worker home visits (for ADI) and absences from study area

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Active surveillance for infection
C1827061 (UMLS CUI-1)
Item
Field worker visit No.
integer
C0545082 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Field worker visit No.
Code List
Field worker visit No.
CL Item
56 (1)
CL Item
57 (2)
CL Item
58 (3)
CL Item
59 (4)
Visit performed
Item
Has the child been visited by the field worker?
boolean
C0545082 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
History of fever
Item
History of fever?
boolean
C0015967 (UMLS CUI [1])
Axillary temperature
Item
Axillary temperature:
float
C1531924 (UMLS CUI [1])
Parasite genotyping blood sample
Item
Blood sample taken for parasite genotyping?
boolean
C1277698 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C1285573 (UMLS CUI [1,3])
Blood smear
Item
Smear taken?
boolean
C2238079 (UMLS CUI [1])
Item
Results:
integer
C1254595 (UMLS CUI [1,1])
C2238079 (UMLS CUI [1,2])
Blood smear results
Code List
Results:
CL Item
Not available (1)
CL Item
Negative (2)
CL Item
Positive (*) (3)
Item Group
Absences from study area
C0348080 (UMLS CUI-1)
C0332197 (UMLS CUI-2)
C0681784 (UMLS CUI-3)
Item
Has the subject been absent for more than 2 weeks?
integer
C0332197 (UMLS CUI [1,1])
C0681784 (UMLS CUI [1,2])
Absence for more than 2 weeks
Code List
Has the subject been absent for more than 2 weeks?
CL Item
No (1)
CL Item
Yes → complete the following table (2)
Date subject left study area
Item
Approximate date subject left study area
date
C0332197 (UMLS CUI [1,1])
C0681784 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date subject returned to study area
Item
Approximate date subject returned to study area
date
C0332197 (UMLS CUI [1,1])
C0681784 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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