ID

23903

Description

Study part: Solicited Adverse Events- 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

Keywords

Versions (1)
  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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Solicited Adverse Events- Local Symptoms Group Hib-MenCY or Hib-MenC Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Solicited Adverse Events- Local Symptoms Group Hib-MenCY or Hib-MenC

1 forms  
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS Group Hib-MenCY or Hib-MenC
Description

SOLICITED ADVERSE EVENTS – 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
Description

Hib-MenCY vaccine

Data type

text

Alias
UMLS CUI [1]
C2352428
Redness (RE)
Description

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
Size
Description

size

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Redness occured on day
Description

day redness

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Ongoing after day?
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
Type
Description

Type

Data type

text

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

Swelling

Data type

boolean

Alias
UMLS CUI [1]
C0038999
Size
Description

size

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Swelling occured on day
Description

day Swelling

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Ongoing after day?
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
Type
Description

Type

Data type

text

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

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Description

Intensity

Data type

text

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

day Pain

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Ongoing after day?
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
Type
Description

Type

Data type

text

Alias
UMLS CUI [1]
C0332307
DTPa-HBV-IPV vaccine
Description

DTPa-HBV-IPV vaccine

Data type

text

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

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
Size
Description

size

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Redness occured on day
Description

day redness

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Ongoing after day?
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
Type
Description

Type

Data type

text

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

Swelling

Data type

boolean

Alias
UMLS CUI [1]
C0038999
Size
Description

size

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Swelling occured on day
Description

day Swelling

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Ongoing after day?
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
Type
Description

Type

Data type

text

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

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Description

Intensity

Data type

text

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

day Pain

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Ongoing after day?
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
Type
Description

Type

Data type

text

Alias
UMLS CUI [1]
C0332307
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Similar models

Solicited Adverse Events- Local Symptoms Group Hib-MenCY or Hib-MenC

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS Group Hib-MenCY or Hib-MenC
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Hib-MenCY vaccine or Hib-MenC vaccine
text
C2352428 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
Hib-MenCY vaccine or Hib-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 vaccine
text
C1121707 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
DTPa-HBV-IPV 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)
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