ID

26275

Beskrivning

Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Nyckelord

Versioner (1)
  1. 2017-10-15 2017-10-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

Engelsk

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beskrivning

Protocol

Datatyp

text

Alias
UMLS CUI [1]
C1507394
Activity
Beskrivning

Activity

Datatyp

text

Alias
UMLS CUI [1]
C1512346
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Temperature
Beskrivning

Temperature

Alias
UMLS CUI-1
C0005903
Axillary
Beskrivning

Axillary temperature

Datatyp

boolean

Alias
UMLS CUI [1]
C1531924
Oral
Beskrivning

Oral temperature

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
Rectal
Beskrivning

Rectal temperature

Datatyp

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Beskrivning

Temperature Day 0

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Beskrivning

Temperature Day 0 not taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826301
UMLS CUI [1,2]
C0437722
Temperature Day 1
Beskrivning

Temperature Day 1

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Beskrivning

Temperature Day 1 not taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1442449
UMLS CUI [1,2]
C0437722
Temperature Day 2
Beskrivning

Temperature Day 2

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Beskrivning

Temperature Day 2 not taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3842676
UMLS CUI [1,2]
C0437722
Temperature Day 3
Beskrivning

Temperature Day 3

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Beskrivning

Temperature Day 3 not taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Headache
Beskrivning

Headache

Alias
UMLS CUI-1
C0018681
Intensity Day 0
Beskrivning

Intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beskrivning

Intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beskrivning

Intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beskrivning

Intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Malaise
Beskrivning

Malaise

Alias
UMLS CUI-1
C0231218
Intensity Day 0
Beskrivning

Intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beskrivning

Intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beskrivning

Intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beskrivning

Intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Fatigue
Beskrivning

Fatigue

Alias
UMLS CUI-1
C0015672
Intensity Day 0
Beskrivning

Intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beskrivning

Intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beskrivning

Intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beskrivning

Intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Nausea
Beskrivning

Nausea

Alias
UMLS CUI-1
C0027497
Intensity Day 0
Beskrivning

Intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beskrivning

Intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beskrivning

Intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beskrivning

Intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Vomiting
Beskrivning

Vomiting

Alias
UMLS CUI-1
C0042963
Intensity Day 0
Beskrivning

Intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beskrivning

Intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beskrivning

Intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beskrivning

Intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Other General Symptoms
Beskrivning

Other General Symptoms

Alias
UMLS CUI-1
C0029625
OTHER : Please give details below (description - start date - end date - intensity)
Beskrivning

Description, start date, end date, intensity

Datatyp

text

Alias
UMLS CUI [1]
C0424450
UMLS CUI [2]
C0808070
UMLS CUI [3]
C0806020
UMLS CUI [4]
C0518690
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Similar models

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Axillary temperature
Item
Axillary
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral
boolean
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Rectal temperature
Item
Rectal
boolean
C0489749 (UMLS CUI [1])
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Temperature Day 0 not taken
Item
Not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Temperature Day 1 not taken
Item
Not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Temperature Day 2 not taken
Item
Not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Temperature Day 3 not taken
Item
Not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Item Group
Headache
C0018681 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Malaise
C0231218 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Fatigue
C0015672 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Nausea
C0027497 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Vomiting
C0042963 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Other General Symptoms
C0029625 (UMLS CUI-1)
Description, start date, end date, intensity
Item
OTHER : Please give details below (description - start date - end date - intensity)
text
C0424450 (UMLS CUI [1])
C0808070 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0518690 (UMLS CUI [4])
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