ID
29748
Description
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
Lien
https://clinicaltrials.gov/show/NCT00197028
Mots-clés
Versions (1)
- 18/04/2018 18/04/2018 -
Détendeur de droits
GlaxoSmithKline (GSK)
Téléchargé le
18 avril 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
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
Description
Reference Range
Alias
- UMLS CUI-1
- C0883335
Description
Date of reference range
Type de données
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Description
Age range
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Description
Age units
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0001779
Description
Sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Laboratory Test
Type de données
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Laboratory test unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0439148
Description
Low Reference Value
Type de données
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205251
Description
High Reference value
Type de données
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1522609
- UMLS CUI [1,3]
- C0205250
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
Center number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Country
Type de données
text
Alias
- UMLS CUI [1]
- C0454664
Description
GSK Receipt Date
Type de données
date
Alias
- UMLS CUI [1]
- C2985846
Description
Subject Number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Type of information
Type de données
integer
Alias
- UMLS CUI [1]
- C1508263
Description
Serious adverse event number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Section 1
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1828479
Description
Event
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Description
Start date
Type de données
date
Alias
- UMLS CUI [1]
- C2697888
Description
Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
If fatal, record date of death
Type de données
date
Alias
- UMLS CUI [1]
- C2697886
Description
Maximum intensity
Type de données
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Action taken with investigational product(s)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
(*) If yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Relationship to investigational product(s)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Description
HO:Hospitalisation ER:Emergency Room MD:Medical Doctor Refer to protocol for full definition
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1519255
Description
If yes, summarize findings in narrative remarks section of this SAE form.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Description
Section 2
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1710056
Description
Seriousness
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Description
Section 3 - Demography Data
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0011298
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Weight
Type de données
integer
Unités de mesure
- pounds/ounces
Alias
- UMLS CUI [1]
- C0005910
Description
Section 4
Alias
- UMLS CUI-1
- C1828479
Description
Section 5 - Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Description
Causes of SAE
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Section 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1519255
Description
Medical disorders
Type de données
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
Description
Date of onset
Type de données
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
Present condition
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
Description
Date of last occurence
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
Description
Section 7 - Other relevant risk factors
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0035648
Description
Section 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Description
Drug name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
Dose
Type de données
integer
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Frequency
Type de données
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medications
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Date started
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Date stopped
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Ongoing
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Section 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Description
Vaccine
Type de données
text
Alias
- UMLS CUI [1]
- C0042210
Description
Dose number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1115464
- UMLS CUI [1,2]
- C0042210
Description
Lot number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Description
Route / site
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2]
- C1515974
Description
Administration date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Description
Randomization code
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0443289
Description
Section 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0220825
Description
Details of relevant assessments
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1261322
- UMLS CUI [1,3]
- C1522508
Description
Section 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Description
Section 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
SAE additional / follow-up information
Type de données
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Description
Administative data
Alias
- UMLS CUI-1
- C1320722
Description
Investigator’s signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Printed name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
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])