ID
29748
Beschrijving
https://clinicaltrials.gov/show/NCT00197028 Sample 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
Voor een aanvraag inloggen.
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
Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events
Beschrijving
Reference Range
Alias
- UMLS CUI-1
- C0883335
Beschrijving
Date of reference range
Datatype
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Beschrijving
Age range
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beschrijving
Age units
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0001779
Beschrijving
Sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Laboratory Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Laboratory test unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0439148
Beschrijving
Low Reference Value
Datatype
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Beschrijving
High Reference value
Datatype
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205250
Beschrijving
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Center number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1]
- C0454664
Beschrijving
GSK Receipt Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985846
Beschrijving
Subject Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Type of information
Datatype
integer
Alias
- UMLS CUI [1]
- C1508263
Beschrijving
Serious adverse event number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Section 1
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1828479
Beschrijving
Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
If fatal, record date of death
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
Maximum intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Action taken with investigational product(s)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
(*) If yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship to investigational product(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschrijving
HO:Hospitalisation ER:Emergency Room MD:Medical Doctor Refer to protocol for full definition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1519255
Beschrijving
If yes, summarize findings in narrative remarks section of this SAE form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Beschrijving
Section 2
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1710056
Beschrijving
Seriousness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Beschrijving
Section 3 - Demography Data
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0011298
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight
Datatype
integer
Maateenheden
- pounds/ounces
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Section 4
Alias
- UMLS CUI-1
- C1828479
Beschrijving
Section 5 - Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Beschrijving
Causes of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Section 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1519255
Beschrijving
Medical disorders
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschrijving
Present condition
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
Beschrijving
Date of last occurence
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
Beschrijving
Section 7 - Other relevant risk factors
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0035648
Beschrijving
Section 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beschrijving
Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medications
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Date started
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Date stopped
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Section 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Beschrijving
Vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C0042210
Beschrijving
Dose number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1115464
- UMLS CUI [1,2]
- C0042210
Beschrijving
Lot number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Beschrijving
Route / site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2]
- C1515974
Beschrijving
Administration date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Beschrijving
Randomization code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0443289
Beschrijving
Section 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0220825
Beschrijving
Details of relevant assessments
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1261322
- UMLS CUI [1,3]
- C1522508
Beschrijving
Section 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Beschrijving
Section 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beschrijving
SAE additional / follow-up information
Datatype
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Beschrijving
Administative data
Alias
- UMLS CUI-1
- C1320722
Similar models
Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events
C0805701 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0011298 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C1261322 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])