ID

34655

Beschreibung

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Stichworte

Versionen (2)
  1. 18.01.19 18.01.19 -
  2. 22.01.19 22.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Januar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

Englisch

Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Reason for non participation; Local symptoms; General Symptoms

1 Formulare  
Tracking Document Reason for non participation
Beschreibung

Tracking Document Reason for non participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Previous Subject Number
Beschreibung

Previous Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Previous studies
Beschreibung

Previous studies

Datentyp

integer

Alias
UMLS CUI [1]
C2242969
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Beschreibung

Please document reason for non participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Subject non eligible - Criteria that are not fulfilled
Beschreibung

Subject non eligible - Criteria that are not fulfilled

Datentyp

text

Alias
UMLS CUI [1]
C3242266
specification of Adverse events, or serious adverse event
Beschreibung

specification of Adverse events, or serious adverse event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
Other reason for non participation
Beschreibung

Other reason for non participation

Datentyp

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Date of Contact
Beschreibung

Date of Contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Center
Beschreibung

Center

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Investigator Name
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Local Symptoms
Beschreibung

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local symptoms
Beschreibung

Local symptoms

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness, Swelling Size/ Day 0
Beschreibung

Size/ Intensity Day 0

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain Intensity Day 0
Beschreibung

Pain Intensity Day 0

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness, Swelling Size/ Day 1 Evening
Beschreibung

Redness, Swelling Size/ Day 1 Evening

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain Intensity Day 1 Evening
Beschreibung

Pain Intensity Day 1 Evening

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Swelling Size/ Day 2 Evening
Beschreibung

Redness, Swelling Size/ Day 2 Evening

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain Intensity Day 2 Evening
Beschreibung

Pain Intensity Day 2 Evening

Datentyp

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Swelling Size/ Day 3 Evening
Beschreibung

Swelling Size/ Day 3 Evening

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain Intensity Day 3 Evening
Beschreibung

Pain Intensity Day 3 Evening

Datentyp

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

Alias
UMLS CUI [1]
C0549178
Date of last Day of Symptoms
Beschreibung

Date of last Day of Symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
Medically attended Visit?
Beschreibung

Medically attended Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Other local Symptoms
Beschreibung

Other local Symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Description - please specify side(s) and site(s)
Beschreibung

Description - please specify side(s) and site(s)

Datentyp

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C2348235
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C2348235
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End date, if not continuing.
Beschreibung

End date, if not continuing.

Datentyp

date

Alias
UMLS CUI [1]
C0806020
If continuing check box
Beschreibung

If continuing check box

Datentyp

integer

Alias
UMLS CUI [1]
C0549178
Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
General Symptoms
Beschreibung

General Symptoms

Alias
UMLS CUI-1
C0159028
Temperature (axillary) Day 0
Beschreibung

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) Day 1
Beschreibung

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) Day 2
Beschreibung

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) Day 3
Beschreibung

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature - Ongoing after Day 3?
Beschreibung

Temperature - Ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0549178
Date of last Day of Temperature
Beschreibung

Date of last Day of Temperature

Datentyp

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0806020
Temperature - Medically attended visit?
Beschreibung

Temperature - Medically attended visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
UMLS CUI [1,4]
C0005903
Intensity of Irratibility/ Fusiness Day 0
Beschreibung

Intensity of Irratibility/ Fusiness Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness Day 1
Beschreibung

Intensity of Irratibility/ Fusiness Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness Day 2
Beschreibung

Intensity of Irratibility/ Fusiness Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness Day 3
Beschreibung

Intensity of Irratibility/ Fusiness Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
Beschreibung

I.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C2721683
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Beschreibung

Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2,1]
C0438697
UMLS CUI [2,2]
C0449238
Irritability/ Fussiness - Ongoing after Day 3?
Beschreibung

Irritability/ Fussiness - Ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last Day of Irritability/ Fussiness
Beschreibung

Date of last Day of Irritability/ Fussiness

Datentyp

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0806020
Irritability/ Fusiness - Medically attended Visit?
Beschreibung

Irritability/ Fusiness - Medically attended Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
Intensity of Drowsiness Day 0
Beschreibung

Intensity of Drowsiness Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness Day 1
Beschreibung

Intensity of Drowsiness Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness Day 2
Beschreibung

Intensity of Drowsiness Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness Day 3
Beschreibung

Intensity of Drowsiness Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Drowsiness - Ongoing after Day 3?
Beschreibung

Drowsiness - Ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last Day of Drowsiness
Beschreibung

Date of last Day of Drowsiness

Datentyp

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0806020
Drowsiness - Medically attended Visit?
Beschreibung

Drowsiness - Medically attended Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Intensity of Loss of appetite Day 0
Beschreibung

Intensity of Loss of appetite Day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite Day 1
Beschreibung

Intensity of Loss of appetite Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite Day 2
Beschreibung

Intensity of Loss of appetite Day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite Day 3
Beschreibung

Intensity of Loss of appetite Day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Loss of appetite - Ongoing after Day 3?
Beschreibung

Loss of appetite - Ongoing after Day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last Day of Loss of appetite
Beschreibung

Date of last Day of Loss of appetite

Datentyp

text

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0806020
Loss of appetite - Medically attended Visit?
Beschreibung

Loss of appetite - Medically attended Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Other general symptoms
Beschreibung

Other general symptoms

Alias
UMLS CUI-1
C0029625
Description - please give details below
Beschreibung

Description - please give details below

Datentyp

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2]
C1522508
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
General Symptoms Start date
Beschreibung

General Symptoms Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0808070
General Symptoms End date
Beschreibung

Check box if continuous

Datentyp

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0806020
Check box, if general symptoms are continuing.
Beschreibung

Check box, if general symptoms are continuing.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Reason for non participation; Local symptoms; General Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Tracking Document Reason for non participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Previous Subject Number
Item
Previous Subject Number
text
C2348585 (UMLS CUI [1])
Item
Previous studies
integer
C2242969 (UMLS CUI [1])
Previous studies
Code List
Previous studies
CL Item
759346/004 (DTPwHB/HibMenAC-TT-004) (1)
CL Item
100791(DTPW-HBV=HIB-MENAC-TT-013) (2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Please document reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? (Please specify criteria that are not fulfilled) (1)
CL Item
Subject lost to follow- up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event (Please specify) (3)
CL Item
Subject eligible but not willing to participate due to other (Please specify) (4)
CL Item
Subject died (please record date of death) (5)
Subject non eligible - Criteria that are not fulfilled
Item
Subject non eligible - Criteria that are not fulfilled
text
C3242266 (UMLS CUI [1])
specification of Adverse events, or serious adverse event
Item
specification of Adverse events, or serious adverse event
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other reason for non participation
Item
Other reason for non participation
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Date of Contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Size/ Intensity Day 0
Item
Redness, Swelling Size/ Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 0
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain Intensity Day 0
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness, Swelling Size/ Day 1 Evening
Item
Redness, Swelling Size/ Day 1 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 1 Evening
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain Intensity Day 1 Evening
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness, Swelling Size/ Day 2 Evening
Item
Swelling Size/ Day 2 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 2 Evening
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 2 Evening
Code List
Pain Intensity Day 2 Evening
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Swelling Size/ Day 3 Evening
Item
Swelling Size/ Day 3 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 3 Evening
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 3 Evening
Code List
Pain Intensity Day 3 Evening
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
Other local Symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0678257 (UMLS CUI [1])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (An adverse even which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
An adverse event which prevents normal, everyday activities [In a young child, such an adverse event would, for example, prevent attendance at school/ kindergarten/ a day- care center and would cause the parents/ guardians to seek medical advice]) (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date, if not continuing.
Item
End date, if not continuing.
date
C0806020 (UMLS CUI [1])
Item
If continuing check box
integer
C0549178 (UMLS CUI [1])
If continuing check box
Code List
If continuing check box
CL Item
Continuing (1)
Medically attended visit?
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Temperature (axillary) Day 0
Item
Temperature (axillary) Day 0
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 1
Item
Temperature (axillary) Day 1
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 2
Item
Temperature (axillary) Day 2
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 3
Item
Temperature (axillary) Day 3
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature - Ongoing after Day 3?
Item
Temperature - Ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Temperature
Item
Date of last Day of Temperature
date
C0005903 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Temperature - Medically attended visit?
Item
Temperature - Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,4])
Item
Intensity of Irratibility/ Fusiness Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 0
Code List
Intensity of Irratibility/ Fusiness Day 0
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 1
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 1
Code List
Intensity of Irratibility/ Fusiness Day 1
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 2
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 2
Code List
Intensity of Irratibility/ Fusiness Day 2
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 3
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 3
Code List
Intensity of Irratibility/ Fusiness Day 3
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2721683 (UMLS CUI [2])
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0438697 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Irritability/ Fussiness - Ongoing after Day 3?
Item
Irritability/ Fussiness - Ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Irritability/ Fussiness
Item
Date of last Day of Irritability/ Fussiness
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Irritability/ Fusiness - Medically attended Visit?
Item
Irritability/ Fusiness - Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Intensity of Drowsiness Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 0
Code List
Intensity of Drowsiness Day 0
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 1
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 1
Code List
Intensity of Drowsiness Day 1
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 2
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 2
Code List
Intensity of Drowsiness Day 2
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 3
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 3
Code List
Intensity of Drowsiness Day 3
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Drowsiness - Ongoing after Day 3?
Item
Drowsiness - Ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Drowsiness
Item
Date of last Day of Drowsiness
date
C0013144 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Drowsiness - Medically attended Visit?
Item
Drowsiness - Medically attended Visit?
boolean
C0013144 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Item
Intensity of Loss of appetite Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 0
Code List
Intensity of Loss of appetite Day 0
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 1
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 1
Code List
Intensity of Loss of appetite Day 1
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 2
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 2
Code List
Intensity of Loss of appetite Day 2
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 3
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 3
Code List
Intensity of Loss of appetite Day 3
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Loss of appetite - Ongoing after Day 3?
Item
Loss of appetite - Ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Loss of appetite
Item
Date of last Day of Loss of appetite
text
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Loss of appetite - Medically attended Visit?
Item
Loss of appetite - Medically attended Visit?
boolean
C1971624 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Item Group
Other general symptoms
C0029625 (UMLS CUI-1)
Description - please give details below
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
Intensity
Item
Intensity
integer
C0518690 (UMLS CUI [1])
General Symptoms Start date
Item
General Symptoms Start date
date
C0159028 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
General Symptoms End date
Item
General Symptoms End date
date
C0159028 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box, if general symptoms are continuing.
integer
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Check box, if general symptoms are continuing.
Code List
Check box, if general symptoms are continuing.
CL Item
General Symptoms continuing (1)
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