ID

26275

Descripción

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

Palabras clave

Versiones (1)
  1. 15/10/17 15/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de octubre de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Protocol
Descripción

Protocol

Tipo de datos

text

Alias
UMLS CUI [1]
C1507394
Activity
Descripción

Activity

Tipo de datos

text

Alias
UMLS CUI [1]
C1512346
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Temperature
Descripción

Temperature

Alias
UMLS CUI-1
C0005903
Axillary
Descripción

Axillary temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1531924
Oral
Descripción

Oral temperature

Tipo de datos

boolean

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

Rectal temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Descripción

Temperature Day 0

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Descripción

Temperature Day 0 not taken

Tipo de datos

boolean

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

Temperature Day 1

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Descripción

Temperature Day 1 not taken

Tipo de datos

boolean

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

Temperature Day 2

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Descripción

Temperature Day 2 not taken

Tipo de datos

boolean

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

Temperature Day 3

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Descripción

Temperature Day 3 not taken

Tipo de datos

boolean

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

Headache

Alias
UMLS CUI-1
C0018681
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Malaise

Alias
UMLS CUI-1
C0231218
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Fatigue

Alias
UMLS CUI-1
C0015672
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Nausea

Alias
UMLS CUI-1
C0027497
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Vomiting

Alias
UMLS CUI-1
C0042963
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Other General Symptoms

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

Description, start date, end date, intensity

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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