ID

34690

Beschrijving

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

Trefwoorden

  1. 23-01-19 23-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

23 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

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

104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms

Local Symptoms
Beschrijving

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Day 0 = date of vaccination
Beschrijving

Date of vaccination

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Local symptoms
Beschrijving

Local symptoms

Datatype

integer

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

Redness/ Swelling - Size Day 0

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 1
Beschrijving

Redness/ Swelling - Size Day 1

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Beschrijving

Redness/ Swelling - Size Day 2

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Beschrijving

Redness/ Swelling - Size Day 3

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 3

Datatype

integer

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

Ongoing after day 3?

Datatype

boolean

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

Date of last Day of Symptoms

Datatype

date

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

Medically attended Visit?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
DTPw/HBV/Hib Vaccine
Beschrijving

DTPw/HBV/Hib Vaccine

Alias
UMLS CUI-1
C0042210
Vaccination side
Beschrijving

Vaccination side

Datatype

text

Alias
UMLS CUI [1]
C0441987
Vaccination site
Beschrijving

Vaccination site

Datatype

text

Alias
UMLS CUI [1]
C1116171
Day 0 = date of vaccination
Beschrijving

Date of vaccination

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
DTPw/HBV/Hib Vaccine - Local Symptoms
Beschrijving

DTPw/HBV/Hib Vaccine - Local Symptoms

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local symptoms
Beschrijving

Local symptoms

Datatype

integer

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

Redness / Swelling - Size Day 0

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness / Swelling - Size Day 1
Beschrijving

Redness / Swelling - Size Day 1

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Beschrijving

Redness/ Swelling - Size Day 2

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Beschrijving

Redness/ Swelling - Size Day 3

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 3

Datatype

integer

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

Ongoing after day 3?

Datatype

boolean

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

Date of last Day of Symptoms

Datatype

date

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

Medically attended Visit?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Meningitec Vaccine
Beschrijving

Meningitec Vaccine

Alias
UMLS CUI-1
C0700144
Vaccination side
Beschrijving

Vaccination side

Datatype

text

Alias
UMLS CUI [1]
C0441987
Vaccination site
Beschrijving

Vaccination site

Datatype

text

Alias
UMLS CUI [1]
C1116171
Day 0 = date of vaccination
Beschrijving

Date of vaccination

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Meningitec Vaccine - Local symptoms
Beschrijving

Meningitec Vaccine - Local symptoms

Alias
UMLS CUI-1
C0700144
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local symptoms
Beschrijving

Local symptoms

Datatype

integer

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

Redness/ Swelling - Size Day 0

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness / Swelling - Size Day 1
Beschrijving

Redness / Swelling - Size Day 1

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Beschrijving

Redness/ Swelling - Size Day 2

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Beschrijving

Redness/ Swelling - Size Day 3

Datatype

integer

Maateenheden
  • 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
Beschrijving

Pain - Intensity Day 3

Datatype

integer

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

Ongoing after day 3?

Datatype

boolean

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

Date of last Day of Symptoms

Datatype

date

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

Medically attended Visit?

Datatype

boolean

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

Other local Symptoms

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

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

Datatype

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
Beschrijving

Intensity

Datatype

integer

Alias
UMLS CUI [1]
C0518690
Start date
Beschrijving

Start date

Datatype

date

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

End date, if not continuing.

Datatype

date

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

If continuing check box

Datatype

integer

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

Medically attended visit?

Datatype

boolean

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

General Symptoms

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

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

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 1 Evening
Beschrijving

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

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 2 Evening
Beschrijving

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

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 3 Evening
Beschrijving

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

Datatype

float

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

Temperature - Ongoing after Day 3?

Datatype

boolean

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

Date of last Day of Temperature

Datatype

date

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

Temperature - Medically attended visit?

Datatype

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
Beschrijving

Intensity of Irratibility/ Fusiness Day 0

Datatype

integer

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

Intensity of Irratibility/ Fusiness - Day 1 Evening

Datatype

integer

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

Intensity of Irratibility/ Fusiness - Day 2 Evening

Datatype

integer

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

Intensity of Irratibility/ Fusiness - Day 3 Evening

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

Irritability/ Fussiness - Ongoing after Day 3?

Datatype

boolean

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

Date of last Day of Irritability/ Fussiness

Datatype

date

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

Irritability/ Fusiness - Medically attended Visit?

Datatype

boolean

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

Intensity of Drowsiness - Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness - Day 1 Evening
Beschrijving

Intensity of Drowsiness - Day 1 Evening

Datatype

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness - Day 2 Evening
Beschrijving

Intensity of Drowsiness - Day 2 Evening

Datatype

integer

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

Intensity of Drowsiness - Day 3 Evening

Datatype

integer

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

Drowsiness - Ongoing after Day 3?

Datatype

boolean

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

Date of last Day of Drowsiness

Datatype

date

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

Drowsiness - Medically attended Visit?

Datatype

boolean

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

Intensity of Loss of appetite - Day 0

Datatype

integer

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

Intensity of Loss of appetite - Day 1 Evening

Datatype

integer

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

Intensity of Loss of appetite - Day 2 Evening

Datatype

integer

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

Intensity of Loss of appetite - Day 3 Evening

Datatype

integer

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

Loss of appetite - Ongoing after Day 3?

Datatype

boolean

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

Date of last Day of Loss of appetite

Datatype

text

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

Loss of appetite - Medically attended Visit?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Day 0 = date of vaccination
Beschrijving

Date of vaccination

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Other general symptoms
Beschrijving

Other general symptoms

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

Description - please give details below

Datatype

text

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

Intensity

Datatype

integer

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

General Symptoms Start date

Datatype

date

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

Check box if continuous

Datatype

date

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

Check box, if general symptoms are continuing.

Datatype

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
Medication
Beschrijving

Medication

Alias
UMLS CUI-1
C0013227
Medication Trade/ Generic name
Beschrijving

Medication Trade/ Generic name

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0592502
Reason for medication
Beschrijving

Reason for medication

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392360
Total daily dose
Beschrijving

Total daily dose

Datatype

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Medication Start date
Beschrijving

Medication Start date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Stop date
Beschrijving

Medication Stop date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box, if continuing
Beschrijving

Tick box, if continuing

Datatype

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178

Similar models

104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Redness/ Swelling - Size 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])
Code List
Pain - Intensity Day 0
CL Item
Absent (0)
CL Item
Minor reaction 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
Item
Redness/ Swelling - Size Day 1
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
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Code List
Pain - Intensity Day 1
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 2
Item
Redness/ Swelling - Size Day 2
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 2
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 3
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
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
DTPw/HBV/Hib Vaccine
C0042210 (UMLS CUI-1)
Item
Vaccination side
text
C0441987 (UMLS CUI [1])
Code List
Vaccination side
CL Item
Left (L)
CL Item
Right (R)
Item
Vaccination site
text
C1116171 (UMLS CUI [1])
Code List
Vaccination site
CL Item
Arm (A)
CL Item
Thigh (T)
CL Item
Buttock (B)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
DTPw/HBV/Hib Vaccine - Local Symptoms
C0042210 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Code List
Local symptoms
CL Item
Redness  (1)
CL Item
Swelling  (2)
CL Item
Pain (3)
Redness / Swelling - Size 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])
Code List
Pain - Intensity Day 0
CL Item
Absent  (0)
CL Item
Minor reaction 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
Item
Redness / Swelling - Size Day 1
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
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Code List
Pain - Intensity Day 1
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 2
Item
Redness/ Swelling - Size Day 2
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 2
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 3
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
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
Meningitec Vaccine
C0700144 (UMLS CUI-1)
Item
Vaccination side
text
C0441987 (UMLS CUI [1])
Code List
Vaccination side
CL Item
Left  (L)
CL Item
Right (R)
Item
Vaccination site
text
C1116171 (UMLS CUI [1])
Code List
Vaccination site
CL Item
Arm  (A)
CL Item
Thigh  (T)
CL Item
Buttock (B)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Meningitec Vaccine - Local symptoms
C0700144 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Code List
Local symptoms
CL Item
Redness  (1)
CL Item
Swelling  (2)
CL Item
Pain (3)
Redness/ Swelling - Size 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])
Code List
Pain - Intensity Day 0
CL Item
Absent  (0)
CL Item
Minor reaction 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
Item
Redness / Swelling - Size Day 1
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
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Code List
Pain - Intensity Day 1
CL Item
Absent  (0)
CL Item
Minor reaction 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
Item
Redness/ Swelling - Size Day 2
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 2
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
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
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
Pain - Intensity Day 3
CL Item
Absent  (0)
CL Item
Minor reaction 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])
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])
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 Evening
Item
Temperature (axillary) - Day 1 Evening
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) - Day 2 Evening
Item
Temperature (axillary) - Day 2 Evening
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) - Day 3 Evening
Item
Temperature (axillary) - Day 3 Evening
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])
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 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Irratibility/ Fusiness - Day 1 Evening
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 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Irratibility/ Fusiness - Day 2 Evening
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 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Irratibility/ Fusiness - Day 3 Evening
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])
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 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Drowsiness - Day 1 Evening
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 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Drowsiness - Day 2 Evening
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 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Drowsiness - Day 3 Evening
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])
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 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Loss of appetite - Day 1 Evening
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 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Loss of appetite - Day 2 Evening
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 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Code List
Intensity of Loss of appetite - Day 3 Evening
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])
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
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])
Code List
Check box, if general symptoms are continuing.
CL Item
General Symptoms continuing (1)
Item Group
Medication
C0013227 (UMLS CUI-1)
Medication Trade/ Generic name
Item
Medication Trade/ Generic name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Reason for medication
Item
Reason for medication
text
C0013227 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Start date
Item
Medication Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication Stop date
Item
Medication Stop date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Tick box, if continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Tick box, if continuing
CL Item
Continuing (1)

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