ID
29749
Beschrijving
https://clinicaltrials.gov/show/NCT00197028 Visit 1 Case Report Form 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)
- 18-04-18 18-04-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
18 april 2018
DOI
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Licentie
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
Case Report Form, Screening, Visit 1
- StudyEvent: ODM
Beschrijving
Informed Consent and Demographics
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C0011298
Beschrijving
Informed Consent Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschrijving
Center Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
integer
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Geographical area
Datatype
integer
Alias
- UMLS CUI [1]
- C0681784
Beschrijving
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
Datatype
integer
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Inclusion criteria
Datatype
integer
Beschrijving
Exclusion Criteria
Datatype
integer
Beschrijving
Screening conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Beschrijving
Serious Adverse Event
Datatype
integer
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Number of SAEs
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschrijving
Screening failure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710477
- UMLS CUI [1,2]
- C0231175
Beschrijving
Screening failure
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1710477
- UMLS CUI [1,2]
- C0231175
Beschrijving
Decision maker
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschrijving
Administative data
Alias
- UMLS CUI-1
- C1320722
Beschrijving
I confirm that I have reviewed the data in these screening forms for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Printed name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Case Report Form, Screening, Visit 1
- StudyEvent: ODM
C0011298 (UMLS CUI-2)
C0021430 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])