ID

24305

Beschreibung

Study part: Diary Card Local Symptoms Group Hib-MenCY or Hib-MenC. 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

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  1. 29.07.17 29.07.17 -
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GlaxoSmithKline

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29. Juli 2017

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Diary Card Local Symptoms Group Hib-MenCY or Hib-MenC Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Englisch

Diary Card Local Symptoms Group Hib-MenCY or Hib-MenC

1 Formulare  
LOCAL SYMPTOMS Group Hib-MenCY or Hib-MenC
Beschreibung

LOCAL SYMPTOMS Group Hib-MenCY or Hib-MenC

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Hib-MenCY vaccine or Hib-MenC vaccine
Beschreibung

for investigator only

Datentyp

boolean

Alias
UMLS CUI [1]
C2352428
Side
Beschreibung

Side

Datentyp

text

Alias
UMLS CUI [1]
C0441987
Site
Beschreibung

Site vaccine

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Redness Size
Beschreibung

Size Redness

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness occured on day
Beschreibung

day redness

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Swelling Size
Beschreibung

Size Swelling

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
mm
Swelling occured on day
Beschreibung

day Swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Pain Intensity
Beschreibung

Intensity Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain occured on day
Beschreibung

day Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Infanrix® penta Vaccine
Beschreibung

Infanrix (DTaP)

Datentyp

boolean

Alias
UMLS CUI [1]
C1964896
Side
Beschreibung

Side

Datentyp

text

Alias
UMLS CUI [1]
C0441987
Site
Beschreibung

Site vaccine

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Redness Size
Beschreibung

Size Redness

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness occured on day
Beschreibung

day redness

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Swelling Size
Beschreibung

Size Swelling

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
mm
Swelling occured on day
Beschreibung

day Swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Pain Intensity
Beschreibung

Intensity Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain occured on day
Beschreibung

day Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Ongoing after day 7?
Beschreibung

symptom ongoing

Datentyp

boolean

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

date last symptoms

Datentyp

date

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
OTHER LOCAL SYMPTOMS
Beschreibung

OTHER LOCAL SYMPTOMS

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Description - please specify side(s) and site(s)
Beschreibung

symptoms local

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Intensity
Beschreibung

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).

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Symptom ongoing
Beschreibung

symptom ongoing

Datentyp

boolean

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

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
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Ähnliche Modelle

Diary Card Local Symptoms Group Hib-MenCY or Hib-MenC

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
LOCAL SYMPTOMS Group Hib-MenCY or Hib-MenC
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Hib-MenCY vaccine
Item
Hib-MenCY vaccine or Hib-MenC vaccine
boolean
C2352428 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1])
Side
Code List
Side
CL Item
Left (Left)
CL Item
Right (Right)
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Site vaccine
Code List
Site
CL Item
Arm (Arm)
CL Item
Thigh (Thigh)
CL Item
Buttock (Buttock)
Size Redness
Item
Redness Size
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Item
Redness occured on day
text
C0439228 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
undefined item
Code List
Redness 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])
Size Swelling
Item
Swelling Size
float
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Item
Swelling occured on day
text
C0439228 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
undefined item
Code List
Swelling 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
Pain Intensity
text
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity
Code List
Pain Intensity
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain occured on day
text
C0439228 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
undefined item
Code List
Pain 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])
Infanrix (DTaP)
Item
Infanrix® penta Vaccine
boolean
C1964896 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1])
Side
Code List
Side
CL Item
Left (Left)
CL Item
Right (Right)
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Site vaccine
Code List
Site
CL Item
Arm (Arm)
CL Item
Thigh (Thigh)
CL Item
Buttock (Buttock)
Size Redness
Item
Redness Size
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Item
Redness occured on day
text
C0439228 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
undefined item
Code List
Redness 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])
Size Swelling
Item
Swelling Size
float
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Item
Swelling occured on day
text
C0439228 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
undefined item
Code List
Swelling 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
Pain Intensity
text
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity
Code List
Pain Intensity
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain occured on day
text
C0439228 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
undefined item
Code List
Pain 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 LOCAL SYMPTOMS
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
symptoms local
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Item
Intensity
integer
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])
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