ID

29763

Description

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

Keywords

Versions (1)
  1. 4/18/18 4/18/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 18, 2018

DOI

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License

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

English

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

1 forms  
Active surveillance for infection
Description

Active surveillance for infection

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

Field worker visit No.

Data type

integer

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

Visit performed

Data type

boolean

Alias
UMLS CUI [1]
C0545082
Date of visit
Description

Date of visit

Data type

date

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

History of fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Axillary temperature:
Description

Axillary temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C1531924
°C
Blood sample taken for parasite genotyping?
Description

Parasite genotyping blood sample

Data type

boolean

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

Blood smear

Data type

boolean

Alias
UMLS CUI [1]
C2238079
Results:
Description

Blood smear results

Data type

integer

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

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?
Description

Absence for more than 2 weeks

Data type

integer

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

Date subject left study area

Data type

date

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

Date subject returned to study area

Data type

date

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0681784
UMLS CUI [1,3]
C0011008
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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