ID

29760

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Visit 10, Day 104-Month 3 1/2, 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

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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

Englisch

Visit 10, Day 104-Month 3 1/2, Laboratory tests

1 Formulare  
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 10?
Beschreibung

Visit 10 participation

Datentyp

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.
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 the decision:
Beschreibung

Withdrawal decision maker

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
History of fever (within the preceding 24 hours)?
Beschreibung

Fever history

Datentyp

boolean

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

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Laboratory tests, Biochemistry
Beschreibung

Laboratory tests, Biochemistry

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

Blood sample

Datentyp

boolean

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

Date of blood sample

Datentyp

date

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

ALT

Datentyp

integer

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0201836
IU/L
Out of range values: Codes
Beschreibung

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

Datentyp

integer

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

Out of ranges values

Datentyp

integer

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0438215
IU/L
Creatinine - test result
Beschreibung

Creatinine

Datentyp

integer

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0201976
μmol/L
Out of range values: Codes
Beschreibung

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

Datentyp

integer

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

Out of ranges values

Datentyp

integer

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Bilirubin - test result
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C1278039
μmol/L
Out of range values: Codes
Beschreibung

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

Datentyp

integer

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

Out of ranges values

Datentyp

float

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Laboratory tests, heamatology
Beschreibung

Laboratory tests, heamatology

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

Blood sample

Datentyp

boolean

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

Date of blood sample

Datentyp

date

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

Haemoglobin

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
WBC (White blood cells) total:
Beschreibung

WBC (White blood cells) total

Datentyp

float

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

PCV (Packed cell volume) / Hematocrit

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0518014
%
Platelets:
Beschreibung

Platelets

Datentyp

integer

Maßeinheiten
  • x 109/L
Alias
UMLS CUI [1]
C0005821
x 109/L
Out of range values: Codes
Beschreibung

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

Datentyp

integer

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

Out of ranges values

Datentyp

float

Alias
UMLS CUI [1]
C0438215
Laboratory tests, Serology and CMI
Beschreibung

Laboratory tests, Serology and CMI

Alias
UMLS CUI-1
C0020966
UMLS CUI-2
C0005834
UMLS CUI-4
C0036743
Has a blood sample been taken for serology (antibodies to CS and antibodies to HBs)?
Beschreibung

Serology blood sample

Datentyp

boolean

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

Blood sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0036743
Has a blood sample been taken for CMI?
Beschreibung

CMI blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020966
UMLS CUI [1,2]
C0005834
Please complete only if different from visit date:
Beschreibung

Blood sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Laboratory tests, Blood film for parasitemia determination
Beschreibung

Laboratory tests, Blood film for parasitemia determination

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

Blood smear

Datentyp

boolean

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

Blood smear date

Datentyp

date

Alias
UMLS CUI [1,1]
C2238079
UMLS CUI [1,2]
C0011008
Results: (*) Child treated for Malaria and Active Detection of Infection (ADI) stops
Beschreibung

Blood smear results

Datentyp

integer

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

Parasite genotyping

Datentyp

boolean

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

Parasite genotyping date

Datentyp

date

Alias
UMLS CUI [1,1]
C1285573
UMLS CUI [1,2]
C0030498
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Ähnliche Modelle

Visit 10, Day 104-Month 3 1/2, Laboratory tests

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 10?
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 10?
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)
(Comment:en)
CL Item
[P] Parents/Guardians (2)
(Comment:en)
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
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, 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 and CMI
C0020966 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0036743 (UMLS CUI-4)
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])
CMI blood sample
Item
Has a blood sample been taken for CMI?
boolean
C0020966 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Blood sample date
Item
Please complete only if different from visit date:
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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 and Active Detection of Infection (ADI) stops
integer
C1167864 (UMLS CUI [1,1])
C1167865 (UMLS CUI [1,2])
Blood smear results
Code List
Results: (*) Child treated for Malaria and Active Detection of Infection (ADI) stops
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])
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