ID

24620

Description

Visit 3 Dose 1 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

Keywords

Versions (3)
  1. 8/8/17 8/8/17 -
  2. 8/15/17 8/15/17 -
  3. 8/24/17 8/24/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 3 Dose 1 General Symptoms Biologicals HepA/HepB vaccine 208127/125

English

Visit 3 Dose 1 General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms  
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
Description

SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
IV. Has the subject experienced any general solicited signs or symptoms since vaccine administration ?
Description

if No: Please, go to paragraph V. if Yes: Please tick a No/Y es box for each symptom. If any experience was observed, please fill in the complete line.

Data type

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C2368628
TE
Description

TE

Alias
UMLS CUI-1
C0005903
Temperature
Description

Temperature increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0205217
Axillary ≥ 37,5°C
Description

Axillary temperature

Data type

boolean

Alias
UMLS CUI [1]
C1531924
Oral ≥ 37,5°C
Description

Oral temperature

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
Rectal ≥ 38°C
Description

Rectal temperature

Data type

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Description

Temperature Day 0

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Description

Temperature Day 0 not taken

Data type

boolean

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

Temperature Day 1

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Description

Temperature Day 1 not taken

Data type

boolean

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

Temperature Day 2

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Description

Temperature Day 2 not taken

Data type

boolean

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

Temperature Day 3

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Description

Temperature Day 3 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
HE
Description

HE

Alias
UMLS CUI-1
C0018681
Headache
Description

General symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
MA
Description

MA

Alias
UMLS CUI-1
C0231218
Malaise
Description

General symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0231218
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
FA
Description

FA

Alias
UMLS CUI-1
C0015672
Fatigue
Description

General symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
NA
Description

NA

Alias
UMLS CUI-1
C0027497
Nausea
Description

General symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0027497
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
VO
Description

VO

Alias
UMLS CUI-1
C0042963
Vomiting
Description

General symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0042963
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy : if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Description

Relation

Data type

text

Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

text

Alias
UMLS CUI [1]
C1705586
Seriousness of symptoms
Description

Seriousness of symptoms

Alias
UMLS CUI-1
C0871902
UMLS CUI-2
C1457887
Do you consider any of these adverse experiences to be serious ?
Description

if Yes: Please report experience to SmithKline Beecham monitor by telephone, telex or telefax withitl 24 hours (see protocol) and complete the SAEF form.

Data type

boolean

Alias
UMLS CUI [1]
C1710056
V. OTHER GENERAL SYMPTOMS
Description

V. OTHER GENERAL SYMPTOMS

Alias
UMLS CUI-1
C0029625
If any general symptom other than those listed above occurred, please complete the Adverse Experience Section.
Description

Complete Adverse Experience Section

Data type

text

Alias
UMLS CUI [1,1]
C0029625
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1521800
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 3 Dose 1 General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Signs or symptoms since vaccine administration
Item
IV. Has the subject experienced any general solicited signs or symptoms since vaccine administration ?
boolean
C0159028 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
TE
C0005903 (UMLS CUI-1)
Temperature increased
Item
Temperature
boolean
C0005903 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Axillary temperature
Item
Axillary ≥ 37,5°C
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral ≥ 37,5°C
boolean
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Rectal temperature
Item
Rectal ≥ 38°C
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])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
HE
C0018681 (UMLS CUI-1)
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Intensity Day 0
Item
Intensity Day 0
integer
C1320357 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 1
Item
Intensity Day 1
integer
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 2
Item
Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 3
Item
Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
MA
C0231218 (UMLS CUI-1)
Malaise
Item
Malaise
boolean
C0231218 (UMLS CUI [1])
Intensity Day 0
Item
Intensity Day 0
integer
C1320357 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 1
Item
Intensity Day 1
integer
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 2
Item
Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 3
Item
Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
FA
C0015672 (UMLS CUI-1)
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Intensity Day 0
Item
Intensity Day 0
integer
C1320357 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 1
Item
Intensity Day 1
integer
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 2
Item
Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 3
Item
Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
NA
C0027497 (UMLS CUI-1)
Nausea
Item
Nausea
boolean
C0027497 (UMLS CUI [1])
Intensity Day 0
Item
Intensity Day 0
integer
C1320357 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 1
Item
Intensity Day 1
integer
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 2
Item
Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 3
Item
Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
VO
C0042963 (UMLS CUI-1)
Vomiting
Item
Vomiting
boolean
C0042963 (UMLS CUI [1])
Intensity Day 0
Item
Intensity Day 0
integer
C1320357 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 1
Item
Intensity Day 1
integer
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 2
Item
Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 3
Item
Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Relation
Item
Relation
text
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Item Group
Seriousness of symptoms
C0871902 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Seriousness of symptoms
Item
Do you consider any of these adverse experiences to be serious ?
boolean
C1710056 (UMLS CUI [1])
Item Group
V. OTHER GENERAL SYMPTOMS
C0029625 (UMLS CUI-1)
Complete Adverse Experience Section
Item
If any general symptom other than those listed above occurred, please complete the Adverse Experience Section.
text
C0029625 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1521800 (UMLS CUI [1,3])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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