ID

29798

Description

https://clinicaltrials.gov/show/NCT00197028 Visit 12, Final study visit, Month 14, Laboratory tests 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 (2)
  1. 4/18/18 4/18/18 -
  2. 4/19/18 4/19/18 - Julian Varghese
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 19, 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 12, Final study visit, Month 14, Laboratory tests

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 12?
Description

Visit 12 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
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory tests, Biochemistry
Description

Laboratory tests, Biochemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005477
Has a blood sample been taken for biochemistry (at Screening - Visit 1)?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date:
Description

Date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
ALT - Test result
Description

ALT

Data type

integer

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0201836
IU/L
Out of range values: Codes
Description

1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well – not investigated further 5: Other, please specify in table above

Data type

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Description

Out of ranges values

Data type

integer

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0438215
IU/L
Creatinine - test result
Description

Creatinine

Data type

integer

Measurement units
  • μmol/L
Alias
UMLS CUI [1]
C0201976
μmol/L
Out of range values: Codes
Description

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Data type

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Description

Out of ranges values

Data type

integer

Measurement units
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Bilirubin - test result
Description

Bilirubin

Data type

float

Measurement units
  • μmol/L
Alias
UMLS CUI [1]
C1278039
μmol/L
Out of range values: Codes
Description

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Data type

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Description

Out of ranges values

Data type

float

Measurement units
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Laboratory tests, heamatology
Description

Laboratory tests, heamatology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Has a blood sample been taken for haematology (at Screening - Visit 1)?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date:
Description

Date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Haemoglobin - test result
Description

Haemoglobin

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
WBC (White blood cells) total:
Description

WBC (White blood cells) total

Data type

float

Measurement units
  • x 109/L
Alias
UMLS CUI [1]
C0023508
x 109/L
PCV (Packed cell volume) / Hematocrit:
Description

PCV (Packed cell volume) / Hematocrit

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0518014
%
Platelets:
Description

Platelets

Data type

integer

Measurement units
  • x 109/L
Alias
UMLS CUI [1]
C0005821
x 109/L
Out of range values: Codes
Description

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Data type

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Description

Out of ranges values

Data type

float

Alias
UMLS CUI [1]
C0438215
Laboratory tests, Serology
Description

Laboratory tests, Serology

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0036743
Has a blood sample been taken for serology (antibodies to CS and antibodies to HBs)?
Description

Serology blood sample

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0036743
Please complete only if different from visit date:
Description

Blood sample date

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0036743
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Similar models

Visit 12, Final study visit, Month 14, Laboratory tests

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 12?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Visit 2 participation
Code List
Did the subject return for visit 12?
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
SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (1)
CL Item
[AEX] Non-Serious adverse event Please specify: ________________________________________________ (2)
CL Item
[OTH] Other, please specify: ____________________________________________ (e.g.: consent withdrawal, Protocol violation, …) (3)
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)
(Comment:en)
CL Item
[P] Parents/Guardians (2)
(Comment:en)
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory tests, Biochemistry
C0022885 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken for biochemistry (at Screening - Visit 1)?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample
Item
Please complete only if different from visit date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ALT
Item
ALT - Test result
integer
C0201836 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well – not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
integer
C0438215 (UMLS CUI [1])
Creatinine
Item
Creatinine - test result
integer
C0201976 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
integer
C0438215 (UMLS CUI [1])
Bilirubin
Item
Bilirubin - test result
float
C1278039 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
float
C0438215 (UMLS CUI [1])
Item Group
Laboratory tests, heamatology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken for haematology (at Screening - Visit 1)?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample
Item
Please complete only if different from visit date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Haemoglobin
Item
Haemoglobin - test result
float
C0518015 (UMLS CUI [1])
WBC (White blood cells) total
Item
WBC (White blood cells) total:
float
C0023508 (UMLS CUI [1])
PCV (Packed cell volume) / Hematocrit
Item
PCV (Packed cell volume) / Hematocrit:
float
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets:
integer
C0005821 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
float
C0438215 (UMLS CUI [1])
Item Group
Laboratory tests, Serology
C0005834 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
Serology blood sample
Item
Has a blood sample been taken for serology (antibodies to CS and antibodies to HBs)?
boolean
C1277698 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
Blood sample date
Item
Please complete only if different from visit date:
date
C1277698 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
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