ID
23901
Beschreibung
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
Stichworte
Versionen (1)
- 17.07.17 17.07.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Juli 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Serious Adverse Events Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381
Serious Adverse Events
- StudyEvent: ODM
Beschreibung
SECTION 1
Alias
- UMLS CUI-1
- C1828479
Beschreibung
Diagnosis only (if known), otherwise sign / symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
If fatal, record date of death
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Maximum intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschreibung
action against SAE
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
subject withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
SAE study drug
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3828190
Beschreibung
Medical advice
Datentyp
integer
Alias
- UMLS CUI [1]
- C1386497
Beschreibung
autopsy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschreibung
SECTION 2 - Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschreibung
Results in death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
life threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschreibung
hospitalisation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
incapacity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3176592
Beschreibung
Congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschreibung
Other
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
SECTION 3 - Demography Data
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Weight
Datentyp
integer
Maßeinheiten
- Pounds
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Weight
Datentyp
integer
Maßeinheiten
- Ounces
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
SECTION 4
Alias
- UMLS CUI-1
- C1828479
Beschreibung
SECTION 5 – Possible causes of SAE other than investigational product
Alias
- UMLS CUI-1
- C0392360
- UMLS CUI-2
- C1519255
Beschreibung
Disease under study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Medical condition
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Lack of efficacy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0235828
Beschreibung
Concomitant medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Activity related to study participation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Other
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
SECTION 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschreibung
medical disorders allergies surgeries
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C0543467
Beschreibung
Date of onset
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Medical Condition SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschreibung
date of last occurrence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschreibung
SECTION 7 – Other relevant risk factors
Alias
- UMLS CUI-1
- C0035648
Beschreibung
SECTION 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Concomitant Medications
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Date started
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Date stopped
Datentyp
date
Alias
- UMLS CUI [1]
- C1531784
Beschreibung
Ongoing medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
SECTION 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
Beschreibung
Vaccine
Datentyp
text
Alias
- UMLS CUI [1]
- C0042210
Beschreibung
Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
Lot
Datentyp
text
Alias
- UMLS CUI [1]
- C1115660
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
randomization code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beschreibung
SECTION 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
Beschreibung
SECTION 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
Beschreibung
SAE treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
SECTION 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C0807975
- UMLS CUI-2
- C1519255
Beschreibung
follow-up information SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0807975
- UMLS CUI [1,2]
- C1519255
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Ähnliche Modelle
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])