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

1 Formulare  
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
Beschreibung

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 ?
Beschreibung

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.

Datentyp

boolean

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

TE

Alias
UMLS CUI-1
C0005903
Temperature
Beschreibung

Temperature increased

Datentyp

boolean

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

Axillary temperature

Datentyp

boolean

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

Oral temperature

Datentyp

boolean

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

Rectal temperature

Datentyp

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Beschreibung

Temperature Day 0

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Beschreibung

Temperature Day 0 not taken

Datentyp

boolean

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

Temperature Day 1

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Beschreibung

Temperature Day 1 not taken

Datentyp

boolean

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

Temperature Day 2

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Beschreibung

Temperature Day 2 not taken

Datentyp

boolean

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

Temperature Day 3

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Beschreibung

Temperature Day 3 not taken

Datentyp

boolean

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
HE
Beschreibung

HE

Alias
UMLS CUI-1
C0018681
Headache
Beschreibung

General symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0018681
Intensity Day 0
Beschreibung

Intensity Day 0

Datentyp

integer

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

Intensity Day 1

Datentyp

integer

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

Intensity Day 2

Datentyp

integer

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

Intensity Day 3

Datentyp

integer

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
MA
Beschreibung

MA

Alias
UMLS CUI-1
C0231218
Malaise
Beschreibung

General symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0231218
Intensity Day 0
Beschreibung

Intensity Day 0

Datentyp

integer

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

Intensity Day 1

Datentyp

integer

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

Intensity Day 2

Datentyp

integer

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

Intensity Day 3

Datentyp

integer

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
FA
Beschreibung

FA

Alias
UMLS CUI-1
C0015672
Fatigue
Beschreibung

General symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0015672
Intensity Day 0
Beschreibung

Intensity Day 0

Datentyp

integer

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

Intensity Day 1

Datentyp

integer

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

Intensity Day 2

Datentyp

integer

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

Intensity Day 3

Datentyp

integer

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
NA
Beschreibung

NA

Alias
UMLS CUI-1
C0027497
Nausea
Beschreibung

General symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0027497
Intensity Day 0
Beschreibung

Intensity Day 0

Datentyp

integer

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

Intensity Day 1

Datentyp

integer

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

Intensity Day 2

Datentyp

integer

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

Intensity Day 3

Datentyp

integer

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
VO
Beschreibung

VO

Alias
UMLS CUI-1
C0042963
Vomiting
Beschreibung

General symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0042963
Intensity Day 0
Beschreibung

Intensity Day 0

Datentyp

integer

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

Intensity Day 1

Datentyp

integer

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

Intensity Day 2

Datentyp

integer

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

Intensity Day 3

Datentyp

integer

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

Corrective therapy : if Yes, record in the Medication Section

Datentyp

boolean

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

Relation

Datentyp

text

Outcome
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Seriousness of symptoms
Beschreibung

Seriousness of symptoms

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

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

Datentyp

boolean

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

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.
Beschreibung

Complete Adverse Experience Section

Datentyp

text

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Beschreibung

day/month/year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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