ID
23901
Description
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
Keywords
Versions (1)
- 7/17/17 7/17/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 17, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Serious Adverse Events Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381
Serious Adverse Events
- StudyEvent: ODM
Description
SECTION 1
Alias
- UMLS CUI-1
- C1828479
Description
Diagnosis only (if known), otherwise sign / symptom
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
If fatal, record date of death
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Maximum intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
action against SAE
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
subject withdrawal
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
SAE study drug
Data type
boolean
Alias
- UMLS CUI [1]
- C3828190
Description
Medical advice
Data type
integer
Alias
- UMLS CUI [1]
- C1386497
Description
autopsy
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
SECTION 2 - Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Results in death
Data type
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
life threatening
Data type
boolean
Alias
- UMLS CUI [1]
- C2826244
Description
hospitalisation
Data type
boolean
Alias
- UMLS CUI [1]
- C0019993
Description
incapacity
Data type
boolean
Alias
- UMLS CUI [1]
- C3176592
Description
Congenital anomaly
Data type
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
Other
Data type
text
Alias
- UMLS CUI [1]
- C0205394
Description
SECTION 3 - Demography Data
Alias
- UMLS CUI-1
- C1704791
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Weight
Data type
integer
Measurement units
- Pounds
Alias
- UMLS CUI [1]
- C0005910
Description
Weight
Data type
integer
Measurement units
- Ounces
Alias
- UMLS CUI [1]
- C0005910
Description
SECTION 4
Alias
- UMLS CUI-1
- C1828479
Description
SECTION 5 – Possible causes of SAE other than investigational product
Alias
- UMLS CUI-1
- C0392360
- UMLS CUI-2
- C1519255
Description
Disease under study
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
Medical condition
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
Lack of efficacy
Data type
boolean
Alias
- UMLS CUI [1]
- C0235828
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Activity related to study participation
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Other
Data type
text
Alias
- UMLS CUI [1]
- C0205394
Description
SECTION 6 – Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
medical disorders allergies surgeries
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C0543467
Description
Date of onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Medical Condition SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Description
date of last occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Description
SECTION 7 – Other relevant risk factors
Alias
- UMLS CUI-1
- C0035648
Description
SECTION 8 – Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Concomitant Medications
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Date started
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
Date stopped
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
Ongoing medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
SECTION 9 – Details of investigational product(s)
Alias
- UMLS CUI-1
- C1828479
Description
Vaccine
Data type
text
Alias
- UMLS CUI [1]
- C0042210
Description
Dose
Data type
text
Alias
- UMLS CUI [1]
- C0178602
Description
Lot
Data type
text
Alias
- UMLS CUI [1]
- C1115660
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
randomization code
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Description
SECTION 10 – Details of relevant assessments
Alias
- UMLS CUI-1
- C1828479
Description
SECTION 11 – Narrative remarks
Alias
- UMLS CUI-1
- C1828479
Description
SAE treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Description
Investigator signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
SECTION 12 – SAE additional / follow-up information
Alias
- UMLS CUI-1
- C0807975
- UMLS CUI-2
- C1519255
Description
follow-up information SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0807975
- UMLS CUI [1,2]
- C1519255
Description
Investigator signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
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])