ID
23901
Beschrijving
Study part: Serious Adverse Events. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381
Trefwoorden
Versies (1)
- 17-07-17 17-07-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 juli 2017
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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Serious Adverse Events Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381
Serious Adverse Events
- StudyEvent: ODM
Beschrijving
SECTION 1
Alias
- UMLS CUI-1
- C1828479
Beschrijving
Diagnosis only (if known), otherwise sign / symptom
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
If fatal, record date of death
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Maximum intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschrijving
action against SAE
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
subject withdrawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
SAE study drug
Datatype
boolean
Alias
- UMLS CUI [1]
- C3828190
Beschrijving
Medical advice
Datatype
integer
Alias
- UMLS CUI [1]
- C1386497
Beschrijving
autopsy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
SECTION 2 - Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Results in death
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
life threatening
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschrijving
hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschrijving
incapacity
Datatype
boolean
Alias
- UMLS CUI [1]
- C3176592
Beschrijving
Congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
Other
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
SECTION 3 - Demography Data
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight
Datatype
integer
Maateenheden
- Pounds
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight
Datatype
integer
Maateenheden
- Ounces
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
SECTION 4
Alias
- UMLS CUI-1
- C1828479
Beschrijving
SECTION 5 – Possible causes of SAE other than investigational product
Alias
- UMLS CUI-1
- C0392360
- UMLS CUI-2
- C1519255
Beschrijving
Disease under study
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Medical condition
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Lack of efficacy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0235828
Beschrijving
Concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Activity related to study participation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Other
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
SECTION 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschrijving
medical disorders allergies surgeries
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C0543467
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Medical Condition SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
date of last occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschrijving
SECTION 7 – Other relevant risk factors
Alias
- UMLS CUI-1
- C0035648
Beschrijving
SECTION 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Concomitant Medications
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Date started
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
Date stopped
Datatype
date
Alias
- UMLS CUI [1]
- C1531784
Beschrijving
Ongoing medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
SECTION 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
Beschrijving
Vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C0042210
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
Lot
Datatype
text
Alias
- UMLS CUI [1]
- C1115660
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
randomization code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beschrijving
SECTION 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
Beschrijving
SECTION 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
Beschrijving
SAE treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
SECTION 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C0807975
- UMLS CUI-2
- C1519255
Beschrijving
follow-up information SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0807975
- UMLS CUI [1,2]
- C1519255
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Serious Adverse Events
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0241889 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
C0740858 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])