ID

29759

Description

https://clinicaltrials.gov/show/NCT00197028 Visit 9, Day 90, First clinic visit for ADI 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

Visit 9, Day 90, First clinic visit for ADI

1 forms  
Check for study continuation
Description

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 9?
Description

Visit 9 participation

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

Withdrawal reason

Data type

integer

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

Withdrawal decision maker

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
History of fever (within the preceding 24 hours)?
Description

Fever history

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Temperature: Route: Axillary
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Laboratory tests, Blood film for parasitemia determination
Description

Laboratory tests, Blood film for parasitemia determination

Alias
UMLS CUI-1
C2239174
UMLS CUI-2
C0024530
Has a smear been taken?
Description

Blood smear

Data type

boolean

Alias
UMLS CUI [1]
C2238079
Please complete only if different from visit date:
Description

Blood smear date

Data type

date

Alias
UMLS CUI [1,1]
C2238079
UMLS CUI [1,2]
C0011008
Results: (*) Child treated for Malaria
Description

Blood smear results

Data type

integer

Alias
UMLS CUI [1,1]
C1167864
UMLS CUI [1,2]
C1167865
Has a blood sample been taken for Parasite genotyping?
Description

Parasite genotyping

Data type

boolean

Alias
UMLS CUI [1,1]
C1285573
UMLS CUI [1,2]
C0030498
Please complete only if different from visit date:
Description

Parasite genotyping date

Data type

date

Alias
UMLS CUI [1,1]
C1285573
UMLS CUI [1,2]
C0030498
Has a blood sample been taken for serology (antibodies to pertussis, diphtheria, PRP, tetanus)?
Description

Serology

Data type

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0022885
Please complete only if different from visit date:
Description

Serology date

Data type

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
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Similar models

Visit 9, Day 90, First clinic visit for ADI

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 9?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Visit 9 participation
Code List
Did the subject return for visit 9?
CL Item
Yes Please complete the next pages.  (1)
CL Item
No Please complete below. (2)
Item
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal reason
Code List
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
[SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (2)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| (3)
CL Item
[OTH] Other, please specify: ____________________________________________________ (e.g.: consent withdrawal, Protocol violation, …) (4)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdrawal decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator  (1)
CL Item
[P] Parents/Guardians (2)
Fever history
Item
History of fever (within the preceding 24 hours)?
boolean
C0015967 (UMLS CUI [1])
Temperature
Item
Temperature: Route: Axillary
float
C0005903 (UMLS CUI [1])
Item Group
Laboratory tests, Blood film for parasitemia determination
C2239174 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
Blood smear
Item
Has a smear been taken?
boolean
C2238079 (UMLS CUI [1])
Blood smear date
Item
Please complete only if different from visit date:
date
C2238079 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Results: (*) Child treated for Malaria
integer
C1167864 (UMLS CUI [1,1])
C1167865 (UMLS CUI [1,2])
Blood smear results
Code List
Results: (*) Child treated for Malaria
CL Item
Not available  (1)
CL Item
Negative  (2)
CL Item
Positive (*) (3)
Parasite genotyping
Item
Has a blood sample been taken for Parasite genotyping?
boolean
C1285573 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
Parasite genotyping date
Item
Please complete only if different from visit date:
date
C1285573 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
Serology
Item
Has a blood sample been taken for serology (antibodies to pertussis, diphtheria, PRP, tetanus)?
boolean
C0036743 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Serology date
Item
Please complete only if different from visit date:
date
C0036743 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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