ID
29748
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00197028
Nyckelord
Versioner (1)
- 2018-04-18 2018-04-18 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
18 april 2018
DOI
För en begäran logga in.
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
Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events
Beskrivning
Reference Range
Alias
- UMLS CUI-1
- C0883335
Beskrivning
Date of reference range
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Beskrivning
Age range
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beskrivning
Age units
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0001779
Beskrivning
Sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Laboratory Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Laboratory test unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0439148
Beskrivning
Low Reference Value
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Beskrivning
High Reference value
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205250
Beskrivning
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Center number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1]
- C0454664
Beskrivning
GSK Receipt Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
Subject Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Type of information
Datatyp
integer
Alias
- UMLS CUI [1]
- C1508263
Beskrivning
Serious adverse event number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Section 1
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1828479
Beskrivning
Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Beskrivning
Start date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
If fatal, record date of death
Datatyp
date
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
Maximum intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Action taken with investigational product(s)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
(*) If yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relationship to investigational product(s)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beskrivning
HO:Hospitalisation ER:Emergency Room MD:Medical Doctor Refer to protocol for full definition
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1519255
Beskrivning
If yes, summarize findings in narrative remarks section of this SAE form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Beskrivning
Section 2
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1710056
Beskrivning
Seriousness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Beskrivning
Section 3 - Demography Data
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight
Datatyp
integer
Måttenheter
- pounds/ounces
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Section 4
Alias
- UMLS CUI-1
- C1828479
Beskrivning
Section 5 - Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Beskrivning
Causes of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beskrivning
Section 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1519255
Beskrivning
Medical disorders
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
Beskrivning
Date of onset
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beskrivning
Present condition
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
Beskrivning
Date of last occurence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
Beskrivning
Section 7 - Other relevant risk factors
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0035648
Beskrivning
Section 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Beskrivning
Drug name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beskrivning
Dose
Datatyp
integer
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beskrivning
Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beskrivning
Concomitant Medications
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Date started
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Date stopped
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Section 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Beskrivning
Vaccine
Datatyp
text
Alias
- UMLS CUI [1]
- C0042210
Beskrivning
Dose number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1115464
- UMLS CUI [1,2]
- C0042210
Beskrivning
Lot number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Beskrivning
Route / site
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2]
- C1515974
Beskrivning
Administration date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Beskrivning
Randomization code
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0443289
Beskrivning
Section 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0220825
Beskrivning
Details of relevant assessments
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1261322
- UMLS CUI [1,3]
- C1522508
Beskrivning
Section 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Beskrivning
Section 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beskrivning
SAE additional / follow-up information
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Beskrivning
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])