ID

24688

Descripción

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline 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 This form contains the Diary Card

Palabras clave

Versiones (1)
  1. 13/8/17 13/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303

Inglés

GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303

1 formularios  
Local Symptoms
Descripción

Local Symptoms

Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness size
Descripción

Redness size

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
Redness Day 0
Descripción

Redness Day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
Redness Day 1
Descripción

Redness Day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
Redness Day 2
Descripción

Redness Day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
Redness Day 3
Descripción

Redness Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last Day of Symptoms
Descripción

Date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended Visit?
Descripción

Medically attended Visit?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Descripción

Swelling

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling Day 0
Descripción

Swelling Day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Swelling Day 1
Descripción

Swelling Day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Swelling Day 2
Descripción

Swelling Day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Swelling Day 3
Descripción

Swelling Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Swelling ongoing after day 3?
Descripción

Swelling ongoing after day 3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last Day of Symptoms
Descripción

Date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain Intensity
Descripción

Intensity Pain

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain intensity day 0
Descripción

Pain intensity day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain intensity day 1
Descripción

Pain intensity day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain intensity day 2
Descripción

Pain intensity day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain intensity day 3
Descripción

Pain intensity day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Pain ongoing after day 3?
Descripción

Pain ongoing after day 3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit Type
Descripción

Medically attended visit Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0426576
Other local symptoms
Descripción

Other local symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Other local symptoms Description
Descripción

Other local symptoms Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Other local symptoms Description
Descripción

Other local symptoms Description

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Start date
Descripción

Start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
End date
Descripción

End date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Ongoing?
Descripción

Adverse Event Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826663
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
General Symptoms
Descripción

General Symptoms

Alias
UMLS CUI-1
C0159028
Day 0
Descripción

start date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Temperature (Evening)
Descripción

Temperature (Evening)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005903
Temperature
Descripción

Temperature (Evening)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005903
Temperature Day 0
Descripción

Temperature Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005903
Temperature Day 1
Descripción

Temperature Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005903
Temperature Day 2
Descripción

Temperature Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005903
Temperature Day 3
Descripción

Temperature Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005903
Temperature Ongoing after Day 3?
Descripción

Temperature

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descripción

Date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Irritability/Fussiness
Descripción

Irritability/Fussiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022107
Irritability Fussiness Intensity Day 0
Descripción

Irritability Fussiness Intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability Fussiness Intensity Day 1
Descripción

Irritability Fussiness Intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability Fussiness Intensity Day 2
Descripción

Irritability Fussiness Intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability Fussiness Intensity Day 3
Descripción

Irritability Fussiness Intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descripción

Date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Drowsiness
Descripción

Drowsiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness Day 0
Descripción

Drowsiness Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness Day 1
Descripción

Drowsiness Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness Day 2
Descripción

Drowsiness Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness Day 3
Descripción

Drowsiness Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Loss of appetite
Descripción

Loss of appetite

Tipo de datos

boolean

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

Loss of appetite Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite Day 1
Descripción

Loss of appetite Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite Day 2
Descripción

Loss of appetite Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite Day 3
Descripción

Loss of appetite Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Other general Symptoms
Descripción

Other general Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1457887
Other general Symptoms
Descripción

Other general Symptoms

Tipo de datos

text

Alias
UMLS CUI [1]
C1457887
Other general Symptoms
Descripción

Other general Symptoms

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0522510
Start date
Descripción

Start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1457887
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
Continuing?
Descripción

Continuing?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Medically attended visit?
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medication
Descripción

Medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
Trade Generic name
Descripción

Trade Generic name

Tipo de datos

text

Alias
UMLS CUI [1]
C0592502
Medication Reason
Descripción

Medication Reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0205476
UMLS CUI [1,4]
C0348080
Total Daily Dose
Descripción

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Continuing
Descripción

Continuing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C0013227
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Local Symptoms
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness size
Item
Redness size
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Day 0
Item
Redness Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Day 1
Item
Redness Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Day 2
Item
Redness Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Day 3
Item
Redness Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 0
Item
Swelling Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 1
Item
Swelling Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 2
Item
Swelling Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 3
Item
Swelling Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain Intensity
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity Pain
Code List
Pain Intensity
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 0
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pain intensity day 0
Code List
Pain intensity day 0
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 1
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pain intensity day 0
Code List
Pain intensity day 1
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 2
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pain intensity day 0
Code List
Pain intensity day 2
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 3
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pain intensity day 0
Code List
Pain intensity day 3
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0426576 (UMLS CUI [1,4])
Medically attended visit Type
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
Other local symptoms
Item
Other local symptoms
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Other local symptoms Description
Item
Other local symptoms Description
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Item
Other local symptoms Description
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Other local symptoms Description
Code List
Other local symptoms Description
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. In a young child, such an adverse event would, for example, prevent attendance at school or kindergarten or a day care center and would cause the parents or guardians to seek medical advice. (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Adverse Event Ongoing
Item
Ongoing?
boolean
C2826663 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
start date
Item
Day 0
date
C0808070 (UMLS CUI [1])
Temperature (Evening)
Item
Temperature (Evening)
boolean
C0005903 (UMLS CUI [1])
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Temperature (Evening)
Code List
Temperature
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Temperature Day 0
Item
Temperature Day 0
integer
C0005903 (UMLS CUI [1])
Temperature Day 1
Item
Temperature Day 1
integer
C0005903 (UMLS CUI [1])
Temperature Day 2
Item
Temperature Day 2
integer
C0005903 (UMLS CUI [1])
Temperature Day 3
Item
Temperature Day 3
integer
C0005903 (UMLS CUI [1])
Temperature
Item
Temperature Ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability Fussiness Intensity Day 0
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability Fussiness Intensity Day 1
Code List
Irritability Fussiness Intensity 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
Irritability Fussiness Intensity Day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability Fussiness Intensity Day 1
Code List
Irritability Fussiness Intensity 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
Irritability Fussiness Intensity Day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability Fussiness Intensity Day 1
Code List
Irritability Fussiness Intensity 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
Irritability Fussiness Intensity Day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability Fussiness Intensity Day 1
Code List
Irritability Fussiness Intensity 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)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness Day 0
integer
C0013144 (UMLS CUI [1])
Drowsiness Day 1
Code List
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
Drowsiness Day 1
integer
C0013144 (UMLS CUI [1])
Drowsiness Day 1
Code List
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
Drowsiness Day 2
integer
C0013144 (UMLS CUI [1])
Drowsiness Day 1
Code List
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
Drowsiness Day 3
integer
C0013144 (UMLS CUI [1])
Drowsiness Day 1
Code List
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)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite Day 0
integer
C1971624 (UMLS CUI [1])
Loss of appetite Day 0
Code List
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
Not eating at all (3)
Item
Loss of appetite Day 1
integer
C1971624 (UMLS CUI [1])
Loss of appetite Day 0
Code List
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
Not eating at all (3)
Item
Loss of appetite Day 2
integer
C1971624 (UMLS CUI [1])
Loss of appetite Day 0
Code List
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
Not eating at all (3)
Item
Loss of appetite Day 3
integer
C1971624 (UMLS CUI [1])
Loss of appetite Day 0
Code List
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
Not eating at all (3)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Other general Symptoms
Item
Other general Symptoms
boolean
C1457887 (UMLS CUI [1])
Other general Symptoms
Item
Other general Symptoms
text
C1457887 (UMLS CUI [1])
Other general Symptoms
Item
Other general Symptoms
text
C1457887 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Continuing?
Item
Continuing?
boolean
C0549178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medication
Item
Medication
boolean
C0013227 (UMLS CUI [1])
Trade Generic name
Item
Trade Generic name
text
C0592502 (UMLS CUI [1])
Medication Reason
Item
Medication Reason
text
C0332307 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0348080 (UMLS CUI [1,4])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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