ID

24311

Description

Study part: Diary Card General Symptoms All groups. 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)
  1. 7/29/17 7/29/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Diary Card General Symptoms All groups Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Diary Card General Symptoms All groups

1 forms  
GENERAL SYMPTOMS
Description

GENERAL SYMPTOMS

Alias
UMLS CUI-1
C1556354
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Temperature measured on
Description

Fever: Axillary ≥ 37.5°C Rectal ≥ 38°C (Preferably rectal)

Data type

text

Alias
UMLS CUI [1]
C0489453
Fever occured on day
Description

day Fever

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0015967
Ongoing after day 7?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medical advice?
Description

Medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
Irritability/ Fussiness
Description

Irritability

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Intensity
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C0518690
Irritability/ Fussiness occured on day
Description

day Irritability

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0022107
Ongoing after day 7?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medical advice?
Description

Medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
Drowsiness
Description

Drowsiness

Data type

boolean

Alias
UMLS CUI [1]
C0013144
Intensity
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C0518690
Drowsiness occured on day
Description

day Drowsiness

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0013144
Ongoing after day 7?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medical advice?
Description

Medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
Loss of appetite
Description

Loss of appetite

Data type

boolean

Alias
UMLS CUI [1]
C1971624
Intensity
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C0518690
Loss of appetite occured on day
Description

day Loss of appetite

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1971624
Ongoing after day 7?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medical advice?
Description

Medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
OTHER GENERAL SYMPTOMS
Description

OTHER GENERAL SYMPTOMS

Alias
UMLS CUI-1
C1457887
Description - please give details below
Description

Description

Data type

text

Alias
UMLS CUI [1]
C0678257
Intensity
Description

1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2:Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3:Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Data type

text

Alias
UMLS CUI [1]
C0518690
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
End date
Description

End date

Data type

date

Alias
UMLS CUI [1]
C0806020
Symptom ongoing
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Medical advice
Description

Medical advice

Data type

boolean

Alias
UMLS CUI [1]
C1386497
MEDICATION
Description

MEDICATION

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Description

Medication

Data type

text

Alias
UMLS CUI [1]
C0013227
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C3146298
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
End date
Description

End date

Data type

date

Alias
UMLS CUI [1]
C0806020
Symptom ongoing
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
IN CASE OF HOSPITALISATION, PLEASE INFORM
Description

Hospitalization

Data type

text

Alias
UMLS CUI [1]
C0019993
Telephone number
Description

Telephone number

Data type

integer

Alias
UMLS CUI [1]
C1515258
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Similar models

Diary Card General Symptoms All groups

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
GENERAL SYMPTOMS
C1556354 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Temperature measured on
text
C0489453 (UMLS CUI [1])
Body temperature measurement site
Code List
Temperature measured on
CL Item
Axillary [A] (1)
CL Item
Rectal [R] (2)
Item
Fever occured on day
text
C0439228 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
undefined item
Code List
Fever occured on day
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
symptom ongoing
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Irritability
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 Behavior as usual (1)
CL Item
1 Crying more than usual / no effect on normal activity (2)
CL Item
2 Crying more than usual / interferes with normal activity (3)
CL Item
3 Crying that cannot be comforted / prevents normal activity (4)
Item
Irritability/ Fussiness occured on day
text
C0439228 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
undefined item
Code List
Irritability/ Fussiness occured on day
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
symptom ongoing
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 Behavior as usual (1)
CL Item
1 Drowsiness easily tolerated (2)
CL Item
2 Drowsiness that interferes with normal activity (3)
CL Item
3 Drowsiness that prevents normal activity (4)
Item
Drowsiness occured on day
text
C0439228 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
undefined item
Code List
Drowsiness occured on day
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
symptom ongoing
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 Normal (1)
CL Item
1 Eating less than usual / no effect on normal activity (2)
CL Item
2 Eating less than usual / interferes with normal activity (3)
CL Item
3 Not eating at all (4)
Item
Loss of appetite occured on day
text
C0439228 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
undefined item
Code List
Loss of appetite occured on day
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
symptom ongoing
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item Group
OTHER GENERAL SYMPTOMS
C1457887 (UMLS CUI-1)
Description
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
symptom ongoing
Item
Symptom ongoing
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Medication
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1])
Reason
Item
Reason
text
C3146298 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
symptom ongoing
Item
Symptom ongoing
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
C0011008 (UMLS CUI [1])
Hospitalization
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text
C0019993 (UMLS CUI [1])
Telephone number
Item
Telephone number
integer
C1515258 (UMLS CUI [1])
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