ID

23904

Beschreibung

Study part: Solicited Adverse Events- Local Symptoms Group Control. 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

Stichworte

Versionen (1)
  1. 17.07.17 17.07.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Juli 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Solicited Adverse Events- Local Symptoms Group Control Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Englisch

Solicited Adverse Events- Local Symptoms Group Control

1 Formulare  
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS Group Control
Beschreibung

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS Group Control

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0009932
MenC vaccine
Beschreibung

MenC vaccine

Datentyp

text

Alias
UMLS CUI [1]
C1720015
Redness (RE)
Beschreibung

Redness

Datentyp

boolean

Alias
UMLS CUI [1]
C0332575
Size
Beschreibung

size

Datentyp

float

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

day redness

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Swelling (SW)
Beschreibung

Swelling

Datentyp

boolean

Alias
UMLS CUI [1]
C0038999
Size
Beschreibung

size

Datentyp

float

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

day Swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Pain (PA)
Beschreibung

Pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Beschreibung

Intensity

Datentyp

text

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

day Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
DTPa-HBV-IPV/Hib vaccine
Beschreibung

DTPa-HBV-IPV/Hib vaccine

Datentyp

text

Alias
UMLS CUI [1]
C1121707
Redness (RE)
Beschreibung

Redness

Datentyp

boolean

Alias
UMLS CUI [1]
C0332575
Size
Beschreibung

size

Datentyp

float

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

day redness

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Swelling (SW)
Beschreibung

Swelling

Datentyp

boolean

Alias
UMLS CUI [1]
C0038999
Size
Beschreibung

size

Datentyp

float

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

day Swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Pain (PA)
Beschreibung

Pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Beschreibung

Intensity

Datentyp

text

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

day Pain

Datentyp

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
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
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type
Beschreibung

Type

Datentyp

text

Alias
UMLS CUI [1]
C0332307
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Solicited Adverse Events- Local Symptoms Group Control

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS Group Control
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0009932 (UMLS CUI-4)
Item
MenC vaccine
text
C1720015 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
MenC vaccine
CL Item
No [N] (1)
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
CL Item
Yes [Y] (4)
Redness
Item
Redness (RE)
boolean
C0332575 (UMLS CUI [1])
size
Item
Size
float
C0456389 (UMLS CUI [1])
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?
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
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)
Swelling
Item
Swelling (SW)
boolean
C0038999 (UMLS CUI [1])
size
Item
Size
float
C0456389 (UMLS CUI [1])
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?
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
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)
Pain
Item
Pain (PA)
boolean
C0030193 (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
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?
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
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)
Item
DTPa-HBV-IPV/Hib vaccine
text
C1121707 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
DTPa-HBV-IPV/Hib vaccine
CL Item
No [N] (1)
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
CL Item
Yes [Y] (4)
Redness
Item
Redness (RE)
boolean
C0332575 (UMLS CUI [1])
size
Item
Size
float
C0456389 (UMLS CUI [1])
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?
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
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)
Swelling
Item
Swelling (SW)
boolean
C0038999 (UMLS CUI [1])
size
Item
Size
float
C0456389 (UMLS CUI [1])
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?
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
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)
Pain
Item
Pain (PA)
boolean
C0030193 (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
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?
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
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)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video