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

  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

  1. StudyEvent: ODM
    1. Serious Adverse Events
SERIOUS ADVERSE EVENT
Description

SERIOUS ADVERSE EVENT

Alias
UMLS CUI-1
C1519255
Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Country
Description

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
GSK Receipt Date
Description

Receipt Date

Data type

date

Alias
UMLS CUI [1]
C2985846
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
SAE N°:
Description

SAE number

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
SAE N°:
Description

SAE number

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
1 Initial report
Description

Initial report

Data type

boolean

Alias
UMLS CUI [1]
C0684224
2 Additional info
Description

Additional information

Data type

boolean

Alias
UMLS CUI [1]
C1546922
3 Additional info
Description

Additional information

Data type

boolean

Alias
UMLS CUI [1]
C1546922
4 Additional info
Description

Additional information

Data type

boolean

Alias
UMLS CUI [1]
C1546922
SECTION 1
Description

SECTION 1

Alias
UMLS CUI-1
C1828479
Event
Description

Diagnosis only (if known), otherwise sign / symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
End date
Description

If fatal, record date of death

Data type

date

Alias
UMLS CUI [1]
C0806020
Maximum intensity
Description

Maximum intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action taken with investigational product(s) as a result of the SAE
Description

action against SAE

Data type

integer

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this SAE?
Description

subject withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

SAE study drug

Data type

boolean

Alias
UMLS CUI [1]
C3828190
Medical advice
Description

Medical advice

Data type

integer

Alias
UMLS CUI [1]
C1386497
Was a post-mortem / autopsy performed?
Description

autopsy

Data type

boolean

Alias
UMLS CUI [1]
C0004398
SECTION 2 - Seriousness
Description

SECTION 2 - Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Description

Results in death

Data type

boolean

Alias
UMLS CUI [1]
C0011065
Is life threatening
Description

life threatening

Data type

boolean

Alias
UMLS CUI [1]
C2826244
Requires hospitalisation or prolongation of existing hospitalisation
Description

hospitalisation

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Results in disability / incapacity
Description

incapacity

Data type

boolean

Alias
UMLS CUI [1]
C3176592
Congenital anomaly / birth defect in the offspring
Description

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
Other, specify:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
SECTION 3 - Demography Data
Description

SECTION 3 - Demography Data

Alias
UMLS CUI-1
C1704791
Date of birth:
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex:
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight:
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Description

Weight

Data type

integer

Measurement units
  • Pounds
Alias
UMLS CUI [1]
C0005910
Pounds
Weight
Description

Weight

Data type

integer

Measurement units
  • Ounces
Alias
UMLS CUI [1]
C0005910
Ounces
SECTION 4
Description

SECTION 4

Alias
UMLS CUI-1
C1828479
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Description

recurrence adverse event

Data type

text

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0877248
SECTION 5 – Possible causes of SAE other than investigational product
Description

SECTION 5 – Possible causes of SAE other than investigational product

Alias
UMLS CUI-1
C0392360
UMLS CUI-2
C1519255
Disease under study
Description

Disease under study

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Medical condition(s)
Description

Medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Alias
UMLS CUI [1]
C0235828
Concomitant medication
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g. procedures)
Description

Activity related to study participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
SECTION 6 – Relevant Medical Conditions
Description

SECTION 6 – Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
Description

medical disorders allergies surgeries

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0543467
Date of onset
Description

Date of onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Condition present at time of SAE
Description

Medical Condition SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If no, date of last occurrence
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
SECTION 7 – Other relevant risk factors
Description

SECTION 7 – Other relevant risk factors

Alias
UMLS CUI-1
C0035648
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE:
Description

risk factors family history occupation substance abuse disorder

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C0028811
UMLS CUI [1,4]
C0740858
SECTION 8 – Relevant Concomitant Medications
Description

SECTION 8 – Relevant Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name (Trade name preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Taken prior to study?
Description

Concomitant Medications

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Date started
Description

Date started

Data type

date

Alias
UMLS CUI [1]
C3173309
Date stopped
Description

Date stopped

Data type

date

Alias
UMLS CUI [1]
C1531784
Ongoing medication?
Description

Ongoing medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9 – Details of investigational product(s)
Description

SECTION 9 – Details of investigational product(s)

Alias
UMLS CUI-1
C1828479
Vaccine (specify mixed or separate)
Description

Vaccine

Data type

text

Alias
UMLS CUI [1]
C0042210
Dose N°
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C0178602
Lot N°
Description

Lot

Data type

text

Alias
UMLS CUI [1]
C1115660
Route / site
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Was randomization code broken at investigational site?
Description

randomization code

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0805701
SECTION 10 – Details of relevant assessments
Description

SECTION 10 – Details of relevant assessments

Alias
UMLS CUI-1
C1828479
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE, e.g. laboratory data with units and normal range:
Description

test diagnosis SAE

Data type

text

Alias
UMLS CUI [1,1]
C0392366
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1519255
SECTION 11 – Narrative remarks
Description

SECTION 11 – Narrative remarks

Alias
UMLS CUI-1
C1828479
Provide a brief narrative description of the SAE and details of treatment given:
Description

SAE treatment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Investigator’s signature:
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
SECTION 12 – SAE additional / follow-up information
Description

SECTION 12 – SAE additional / follow-up information

Alias
UMLS CUI-1
C0807975
UMLS CUI-2
C1519255
Use this page to provide any additional details on the SAE not already captured on the previous pages:
Description

follow-up information SAE

Data type

text

Alias
UMLS CUI [1,1]
C0807975
UMLS CUI [1,2]
C1519255
Investigator’s signature:
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008

Similar models

Serious Adverse Events

  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SERIOUS ADVERSE EVENT
C1519255 (UMLS CUI-1)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
SAE number
Item
SAE N°:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
SAE number
Item
SAE N°:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Initial report
Item
1 Initial report
boolean
C0684224 (UMLS CUI [1])
Additional information
Item
2 Additional info
boolean
C1546922 (UMLS CUI [1])
Additional information
Item
3 Additional info
boolean
C1546922 (UMLS CUI [1])
Additional information
Item
4 Additional info
boolean
C1546922 (UMLS CUI [1])
Item Group
SECTION 1
C1828479 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Recovered /resolved (1)
CL Item
Recovering /resolving (2)
CL Item
Not recovered /not resolved (3)
CL Item
Recovered /resolved with sequelae (4)
CL Item
Fatal (5)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Maximum intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action taken with investigational product(s) as a result of the SAE
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose Interrupted (3)
CL Item
Not applicable (4)
subject withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1])
SAE study drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C3828190 (UMLS CUI [1])
Item
Medical advice
integer
C1386497 (UMLS CUI [1])
Code List
Medical advice
CL Item
HO Hospitalisation (1)
CL Item
ER Emergency room (2)
CL Item
MD Medical doctor (3)
autopsy
Item
Was a post-mortem / autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item Group
SECTION 2 - Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life threatening
Item
Is life threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
incapacity
Item
Results in disability / incapacity
boolean
C3176592 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly / birth defect in the offspring
boolean
C2826727 (UMLS CUI [1])
Other
Item
Other, specify:
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 3 - Demography Data
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Item
Sex:
text
C0079399 (UMLS CUI [1])
Code List
Sex:
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight:
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
SECTION 4
C1828479 (UMLS CUI-1)
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0035020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SECTION 5 – Possible causes of SAE other than investigational product
C0392360 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1])
Other
Item
Other, specify:
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 6 – Relevant Medical Conditions
C0012634 (UMLS CUI-1)
medical disorders allergies surgeries
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Medical Condition SAE
Item
Condition present at time of SAE
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
date of last occurrence
Item
If no, date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
SECTION 7 – Other relevant risk factors
C0035648 (UMLS CUI-1)
risk factors family history occupation substance abuse disorder
Item
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE:
text
C0035648 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
C0740858 (UMLS CUI [1,4])
Item Group
SECTION 8 – Relevant Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant Medications
Item
Taken prior to study?
boolean
C2347852 (UMLS CUI [1])
Date started
Item
Date started
date
C3173309 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C1531784 (UMLS CUI [1])
Ongoing medication
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9 – Details of investigational product(s)
C1828479 (UMLS CUI-1)
Vaccine
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
Dose
Item
Dose N°
text
C0178602 (UMLS CUI [1])
Lot
Item
Lot N°
text
C1115660 (UMLS CUI [1])
Route
Item
Route / site
text
C0013153 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Was randomization code broken at investigational site?
text
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Code List
Was randomization code broken at investigational site?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item Group
SECTION 10 – Details of relevant assessments
C1828479 (UMLS CUI-1)
test diagnosis SAE
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE, e.g. laboratory data with units and normal range:
text
C0392366 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
SECTION 11 – Narrative remarks
C1828479 (UMLS CUI-1)
SAE treatment
Item
Provide a brief narrative description of the SAE and details of treatment given:
text
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
SECTION 12 – SAE additional / follow-up information
C0807975 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
follow-up information SAE
Item
Use this page to provide any additional details on the SAE not already captured on the previous pages:
text
C0807975 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])

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