ID

38174

Beskrivning

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Nyckelord

  1. 2019-09-24 2019-09-24 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

24 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Events - Local and General Symptoms

Administration
Beskrivning

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Vaccine Administration
Beskrivning

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Beskrivning

(only one box must be checked)

Datatyp

integer

Alias
UMLS CUI [1]
C2368628
Side/ Site Route
Beskrivning

Side/ Site Route

Datatyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Beskrivning

Has the study vaccine been administered according to the Protocol?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please check all items that apply
Beskrivning

Please check all items

Datatyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Solicited Adverse Events - Local Symptoms
Beskrivning

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
Beskrivning

If yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.

Datatyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0013153
Redness
Beskrivning

Redness

Datatyp

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Beskrivning

Redness size Day 0

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Beskrivning

Redness size Day 1

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Beskrivning

Redness size Day 2

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Beskrivning

Redness size Day 3

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Beskrivning

Redness Ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Beskrivning

If Redness is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Beskrivning

Swelling

Datatyp

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Beskrivning

Swelling Size Day 0

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Beskrivning

Swelling Size Day 1

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Beskrivning

Swelling Size Day 2

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Beskrivning

Swelling Size Day 3

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3? +
Beskrivning

Swelling Ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Beskrivning

If Swelling is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Beskrivning

Pain intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Beskrivning

Pain intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Beskrivning

Pain intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Beskrivning

Pain intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Beskrivning

Pain Ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Beskrivning

If Pain is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - General Symptoms
Beskrivning

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
Beskrivning

If Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.

Datatyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0159028
Fever
Beskrivning

Rectal > 100.4°F (38°C) Axillary > 99.5°F (37.5°C) Tympanic oral > 99.5°F (37.5°C) Tympanic rectal > 100.4°F (38°C)

Datatyp

boolean

Alias
UMLS CUI [1]
C0015967
Temperature Route
Beskrivning

Temperature Route

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Temperature Day 0
Beskrivning

Temperature Day 0

Datatyp

float

Måttenheter
  • °F
Alias
UMLS CUI [1]
C0005903
°F
Temperature not taken Day 0
Beskrivning

Temperature not taken Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 1
Beskrivning

Temperature Day 1

Datatyp

float

Måttenheter
  • °F
Alias
UMLS CUI [1]
C0005903
°F
Temperature not taken Day 1
Beskrivning

Temperature not taken Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 2
Beskrivning

Temperature Day 2

Datatyp

float

Måttenheter
  • °F
Alias
UMLS CUI [1]
C0005903
°F
Temperature not taken Day 2
Beskrivning

Temperature not taken Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 3
Beskrivning

Temperature Day 3

Datatyp

float

Måttenheter
  • °F
Alias
UMLS CUI [1]
C0005903
°F
Temperature not taken Day 3
Beskrivning

Temperature not taken Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C0437722
Fever ongoing after Day 3?
Beskrivning

Fever ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3174772
If Fever is ongoing, record date of last Day of Symptoms
Beskrivning

If Fever is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Fever - Causality?
Beskrivning

Fever - Causality?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0085978
Irritability/ Fussiness
Beskrivning

Irritability/ Fussiness

Datatyp

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/ Fussiness intensity Day 0
Beskrivning

Irritability/ Fussiness intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
Irritability/ Fussiness intensity Day 1
Beskrivning

Irritability/ Fussiness intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
Irritability/ Fussiness intensity Day 2
Beskrivning

Irritability/ Fussiness intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
Irritability/ Fussiness intensity Day 3
Beskrivning

Irritability/ Fussiness intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
Irritability/ Fussiness ongoing after Day 3?
Beskrivning

Irritability/ Fussiness ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C3174772
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Beskrivning

If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C0022107
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Irritability/ Fussiness - Causality?
Beskrivning

Irritability/ Fussiness - Causality?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0085978
Drowsiness
Beskrivning

Drowsiness

Datatyp

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity Day 0
Beskrivning

Drowsiness intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
Drowsiness intensity Day 1
Beskrivning

Drowsiness intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
Drowsiness intensity Day 2
Beskrivning

Drowsiness intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
Drowsiness intensity Day 3
Beskrivning

Drowsiness intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
Drowsiness ongoing after Day 3?
Beskrivning

Drowsiness ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C3174772
If Drowsiness is ongoing, record date of last Day of Symptoms
Beskrivning

If Drowsiness is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Drowsiness - Causality?
Beskrivning

Drowsiness - Causality?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0085978
Loss of appetite
Beskrivning

Loss of appetite

Datatyp

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite intensity Day 0
Beskrivning

Loss of appetite intensity Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
Loss of appetite intensity Day 1
Beskrivning

Loss of appetite intensity Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
Loss of appetite intensity Day 2
Beskrivning

Loss of appetite intensity Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
Loss of appetite intensity Day 3
Beskrivning

Loss of appetite intensity Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
Loss of appetite ongoing after Day 3?
Beskrivning

Loss of appetite ongoing after Day 3?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C3174772
If Loss of appetite is ongoing, record date of last Day of Symptoms
Beskrivning

If Loss of appetite is ongoing, record date of last Day of Symptoms

Datatyp

date

Alias
UMLS CUI [1]
C1971624
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Loss of appetite - Causality?
Beskrivning

Loss of appetite - Causality?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0085978

Similar models

Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Events - Local and General Symptoms

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (comment) (2)
CL Item
Wrong vial number (comment) (3)
CL Item
Not administered (comment) (4)
Item
Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Code List
Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
CL Item
Upper Left (1)
CL Item
Lower Left (2)
CL Item
Upper Right (3)
CL Item
Lower Right (4)
CL Item
Deltoid (5)
CL Item
Thigh (6)
CL Item
s.c. (7)
CL Item
i.m. (8)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Code List
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
CL Item
Unknown (U)
CL Item
No (N)
CL Item
Yes (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3? +
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity Day 1
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
CL Item
Unknown (U)
CL Item
No (N)
CL Item
Yes (Y)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Code List
Temperature Route
CL Item
Rectal (1)
CL Item
Axillary (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 0
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 0
CL Item
Not taken (1)
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 1
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 1
CL Item
Not taken (1)
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 2
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 2
CL Item
Not taken (1)
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 3
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 3
CL Item
Not taken (1)
Fever ongoing after Day 3?
Item
Fever ongoing after Day 3?
boolean
C0015967 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Fever is ongoing, record date of last Day of Symptoms
Item
If Fever is ongoing, record date of last Day of Symptoms
date
C0015967 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Irritability/ Fussiness
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/ Fussiness intensity Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Irritability/ Fussiness intensity Day 1
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Irritability/ Fussiness intensity Day 2
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Irritability/ Fussiness intensity Day 3
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Irritability/ Fussiness ongoing after Day 3?
Item
Irritability/ Fussiness ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Item
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
date
C0022107 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Irritability/ Fussiness - Causality?
Item
Irritability/ Fussiness - Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Drowsiness intensity Day 1
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Drowsiness intensity Day 2
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Drowsiness intensity Day 3
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Drowsiness ongoing after Day 3?
Item
Drowsiness ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Drowsiness is ongoing, record date of last Day of Symptoms
Item
If Drowsiness is ongoing, record date of last Day of Symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Drowsiness - Causality?
Item
Drowsiness - Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite intensity Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Loss of appetite intensity Day 1
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Loss of appetite intensity Day 2
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Item
Loss of appetite intensity Day 3
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (0)
Loss of appetite ongoing after Day 3?
Item
Loss of appetite ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Loss of appetite is ongoing, record date of last Day of Symptoms
Item
If Loss of appetite is ongoing, record date of last Day of Symptoms
date
C1971624 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Loss of appetite - Causality?
Item
Loss of appetite - Causality?
boolean
C1971624 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])

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