ID

23905

Beschreibung

Study part: Solicited Adverse Events- 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

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  1. 17.07.17 17.07.17 -
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GlaxoSmithKline

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17. Juli 2017

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Solicited Adverse Events- General Symptoms All Groups Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Englisch

Solicited Adverse Events- General Symptoms All Groups

1 Formulare  
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Beschreibung

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

Alias
UMLS CUI-1
C1556354
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Has the subject experienced any of the following signs/symptoms during the solicited period?
Beschreibung

Adverse Events General Symptoms

Datentyp

text

Alias
UMLS CUI [1]
C1556354
Fever
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Beschreibung

Fever

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Temperature measured on
Beschreibung

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

Datentyp

text

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

day Fever

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0015967
Ongoing after day?
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
Causality?
Beschreibung

Causality

Datentyp

boolean

Alias
UMLS CUI [1]
C1314792
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Irritability/ Fussiness (IR )
Beschreibung

Irritability

Datentyp

boolean

Alias
UMLS CUI [1]
C0022107
Intensity
Beschreibung

Intensity

Datentyp

text

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

day Irritability

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0022107
Ongoing after day?
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
Causality?
Beschreibung

Causality

Datentyp

boolean

Alias
UMLS CUI [1]
C1314792
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Drowsiness(D R )
Beschreibung

Drowsiness

Datentyp

boolean

Alias
UMLS CUI [1]
C0013144
Intensity
Beschreibung

Intensity

Datentyp

text

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

day Drowsiness

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0013144
Ongoing after day?
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
Causality?
Beschreibung

Causality

Datentyp

boolean

Alias
UMLS CUI [1]
C1314792
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Loss of appetite (LO)
Beschreibung

Loss of appetite

Datentyp

boolean

Alias
UMLS CUI [1]
C1971624
Intensity
Beschreibung

Intensity

Datentyp

text

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

day Loss of appetite

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1971624
Ongoing after day?
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
Causality?
Beschreibung

Causality

Datentyp

boolean

Alias
UMLS CUI [1]
C1314792
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
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Ähnliche Modelle

Solicited Adverse Events- General Symptoms All Groups

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
C1556354 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1556354 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
No [N] (1)
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
CL Item
Yes [Y] (4)
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?
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])
Causality
Item
Causality?
boolean
C1314792 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
text
C0332307 (UMLS CUI [1])
Type
Code List
Type
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Irritability
Item
Irritability/ Fussiness (IR )
boolean
C0022107 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 None (1)
CL Item
1 Mild (2)
CL Item
2 Moderate (3)
CL Item
3 Severe (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?
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])
Causality
Item
Causality?
boolean
C1314792 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
text
C0332307 (UMLS CUI [1])
Type
Code List
Type
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Drowsiness
Item
Drowsiness(D R )
boolean
C0013144 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 None (1)
CL Item
1 Mild (2)
CL Item
2 Moderate (3)
CL Item
3 Severe (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?
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])
Causality
Item
Causality?
boolean
C1314792 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
text
C0332307 (UMLS CUI [1])
Type
Code List
Type
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Loss of appetite
Item
Loss of appetite (LO)
boolean
C1971624 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
0 None (1)
CL Item
1 Mild (2)
CL Item
2 Moderate (3)
CL Item
3 Severe (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?
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])
Causality
Item
Causality?
boolean
C1314792 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
text
C0332307 (UMLS CUI [1])
Type
Code List
Type
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
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