Information:
Fel:
ID
29764
Beskrivning
https://clinicaltrials.gov/show/NCT00197028 Visit 11, Day 180, 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
Länk
https://clinicaltrials.gov/show/NCT00197028
Nyckelord
Versioner (1)
- 2018-04-18 2018-04-18 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
18 april 2018
DOI
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Licens
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
Visit 11, Day 180, Laboratory tests
- StudyEvent: ODM
Similar models
Visit 11, Day 180, Laboratory tests
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 11?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0679006 (UMLS CUI [1,2])
CL Item
[I] Investigator (1)
(Comment:en)
CL Item
[P] Parents/Guardians (2)
(Comment:en)
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)
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])
C0011008 (UMLS CUI [1,2])
ALT
Item
ALT - Test result
integer
C0201836 (UMLS CUI [1])
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])
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])
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)
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])
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])
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)
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])
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])
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])
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])
C0011008 (UMLS CUI [1,2])
Item Group
Laboratory tests, Blood film for parasitemia determination
C2239174 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
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])
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])
C1167865 (UMLS CUI [1,2])
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])
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])
C0030498 (UMLS CUI [1,2])