Informações:
Falhas:
ID
29754
Descrição
https://clinicaltrials.gov/show/NCT00197028 Visit 4, Day 21 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
Palavras-chave
Versões (1)
- 18/04/2018 18/04/2018 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
18 de abril de 2018
DOI
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Licença
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
Similar models
Visit 4, Day 21
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 4?
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
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])
C0679006 (UMLS CUI [1,2])
CL Item
[I] Investigator (1)
(Comment:en)
CL Item
[P] Parents/Guardians (2)
(Comment:en)
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])