ID

29759

Beschrijving

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

Trefwoorden

Versies (1)
  1. 18-04-18 18-04-18 -
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

18 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Visit 9, Day 90, First clinic visit for ADI

1 Formulieren  
Check for study continuation
Beschrijving

Check for study continuation

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

Visit 9 participation

Datatype

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.
Beschrijving

Withdrawal reason

Datatype

integer

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

Withdrawal decision maker

Datatype

integer

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

Fever history

Datatype

boolean

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

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Laboratory tests, Blood film for parasitemia determination
Beschrijving

Laboratory tests, Blood film for parasitemia determination

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

Blood smear

Datatype

boolean

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

Blood smear date

Datatype

date

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

Blood smear results

Datatype

integer

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

Parasite genotyping

Datatype

boolean

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

Parasite genotyping date

Datatype

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)?
Beschrijving

Serology

Datatype

boolean

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

Serology date

Datatype

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Terug naar het begin van de pagina

Similar models

Visit 9, Day 90, First clinic visit for ADI

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial