ID

29350

Descripción

Visit 4 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Palabras clave

Versiones (1)
  1. 20/3/18 20/3/18 -
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

20 de marzo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

Inglés

Visit 4, Month 6, 180 + 21 Days after Visit 1, Dose 3

1 formularios  
Administration
Descripción

Administration

Alias
UMLS CUI-1
C1320722
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Pre-vaccination assessment
Descripción

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0042196
Pre-vaccination temperature
Descripción

Temperature

Tipo de datos

integer

Alias
UMLS CUI [1]
C0039476
Route
Descripción

Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Has a urine sample been taken?
Descripción

URINE SAMPLE (Pregnancy test – HCG) (only if deemed necessary by the investigator).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200354
Urine sample results (Pregnancy test – HCG)
Descripción

Urine sample results, Pregnancy

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0456984
UMLS CUI [2]
C0430056
Vaccine administration
Descripción

Vaccine administration

Alias
UMLS CUI-1
C2368628
Vaccine administration (only one box must be checked)
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Side / site Route Non dominant Deltoid Deep I.M. (Please check appropriate box)
Descripción

Side / site Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the protocol?
Descripción

Vaccine administration according to protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If you answered the previous question with 'No', please check all items: Site
Descripción

If you answered the previous question with 'No', please check all items:

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
If you answered the previous question with 'No', please check all items: Route
Descripción

Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Solicited adverse events - Local Symptoms
Descripción

Solicited adverse events - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
Descripción

Local symptoms

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness
Descripción

Redness

Alias
UMLS CUI-1
C0332575
UMLS CUI-2
C2700396
Redness?
Descripción

Redness

Tipo de datos

boolean

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

Redness day

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Size of local redness
Descripción

Redness size

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Descripción

Ongoing redness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of redness:
Descripción

If you answered the previous question with yes, please specify

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Descripción

Swelling

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C2700396
Swelling?
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling day
Descripción

Swelling day

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Size of local swelling
Descripción

Swelling size

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 ongoing after day 3?
Descripción

Ongoing swelling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of swelling:
Descripción

If you answered the previous question with yes, please specify

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain
Descripción

Pain

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2700396
Pain?
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
Pain day
Descripción

Pain day

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Pain intensity
Descripción

Pain intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Descripción

Ongoing pain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of pain:
Descripción

If you answered the previous question with yes, please specify

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Solicited adverse events - General symptoms
Descripción

Solicited adverse events - General symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
Descripción

General symptoms

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Fever
Descripción

Fever

Alias
UMLS CUI-1
C0015967
Fever?
Descripción

Axillary > 37.5°C Oral > 37.5°C Rectal > 38°C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Route Fever
Descripción

Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Fever not taken?
Descripción

Fever not taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Fever Day
Descripción

Fever Day

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439228
Fever Day
Descripción

Fever Day

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439228
Temperature
Descripción

Temperature

Tipo de datos

integer

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Ongoing after day 3?
Descripción

Ongoing fever

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last fever symptoms
Descripción

Date of last fever symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Fatigue
Descripción

Fatigue

Alias
UMLS CUI-1
C0015672
Fatigue?
Descripción

Fatigue

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015672
Day of fatigue
Descripción

Fatigue day

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015672
Intensity of fatigue
Descripción

Fatigue intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing fatigue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0549178
Date of last symptoms
Descripción

Date of last fatigue symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015672
Headache
Descripción

Headache

Alias
UMLS CUI-1
C0018681
Headache?
Descripción

Headache

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018681
Headache day
Descripción

Headache day

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018681
Headache intensity
Descripción

Headache Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing headache

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0549178
Date of last symptoms
Descripción

Date of last headache symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018681
Gastrointestinal symptoms
Descripción

Gastrointestinal symptoms

Alias
UMLS CUI-1
C0426576
Gastrointestinal symptoms?
Descripción

Gastrointestinal symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms Day
Descripción

Gastrointestinal symptoms Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms Intensity
Descripción

Gastrointestinal symptoms Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing Gastrointestinal symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0549178
Date of last symptoms
Descripción

Date of last Gastrointestinal symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0426576
Causality?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0426576
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Similar models

Visit 4, Month 6, 180 + 21 Days after Visit 1, Dose 3

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Temperature
Item
Pre-vaccination temperature
integer
C0039476 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Urine Sample
Item
Has a urine sample been taken?
boolean
C0200354 (UMLS CUI [1])
Item
Urine sample results (Pregnancy test – HCG)
integer
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0430056 (UMLS CUI [2])
Urine sample results
Code List
Urine sample results (Pregnancy test – HCG)
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Item
Vaccine administration (only one box must be checked)
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration (only one box must be checked)
CL Item
Engerix™-B (20 mg) Thiomersal Free or Engerix™-B (10 mg) Preservative Free (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (*) (4)
Item
Side / site Route Non dominant Deltoid Deep I.M. (Please check appropriate box)
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Side / site Route
Code List
Side / site Route Non dominant Deltoid Deep I.M. (Please check appropriate box)
CL Item
Left (1)
CL Item
Right (2)
Vaccine administration according to 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 you answered the previous question with 'No', please check all items: Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Site
Code List
If you answered the previous question with 'No', please check all items: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If you answered the previous question with 'No', please check all items: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
If you answered the previous question with 'No', please check all items: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Solicited adverse events - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line. (3)
Item Group
Redness
C0332575 (UMLS CUI-1)
C2700396 (UMLS CUI-2)
Redness
Item
Redness?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Redness day
integer
C0439228 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness day
Code List
Redness day
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness size
Item
Size of local redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing redness
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last symptoms of redness
Item
Date of last day of symptoms of redness:
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Swelling
C0038999 (UMLS CUI-1)
C2700396 (UMLS CUI-2)
Swelling
Item
Swelling?
boolean
C0038999 (UMLS CUI [1])
Item
Swelling day
integer
C0439228 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Swelling day
Code List
Swelling day
CL Item
Day 0 6 hours after vaccin.  (1)
CL Item
Day 1  (2)
CL Item
Day 2  (3)
CL Item
Day 3 (4)
Swelling size
Item
Size of local swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing swelling
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last Symptoms of swelling
Item
Date of last day of symptoms of swelling:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Pain
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Pain
Item
Pain?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain day
integer
C0439228 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pain day
Code List
Pain day
CL Item
Day 0 6 hours after vaccin.  (1)
CL Item
Day 1  (2)
CL Item
Day 2  (3)
CL Item
Day 3 (4)
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Code List
Pain intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing pain
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last symptoms of pain
Item
Date of last day of symptoms of pain:
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited adverse events - General symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
General symptoms
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line. (3)
Item Group
Fever
C0015967 (UMLS CUI-1)
Fever
Item
Fever?
boolean
C0015967 (UMLS CUI [1])
Item
Route Fever
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route
Code List
Route Fever
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever not taken
Item
Fever not taken?
boolean
C0015967 (UMLS CUI [1])
Item
Fever Day
integer
C0015967 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Fever Day
Code List
Fever Day
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Fever Day
integer
C0015967 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Fever Day
Code List
Fever Day
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Ongoing fever
Item
Ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last fever symptoms
Item
Date of last fever symptoms
date
C0015967 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item Group
Fatigue
C0015672 (UMLS CUI-1)
Fatigue
Item
Fatigue?
boolean
C0015672 (UMLS CUI [1])
Item
Day of fatigue
integer
C0015672 (UMLS CUI [1])
Fatigue day
Code List
Day of fatigue
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity of fatigue
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue intensity
Code List
Intensity of fatigue
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing fatigue
Item
Ongoing after day 3?
boolean
C0015672 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last fatigue symptoms
Item
Date of last symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Item Group
Headache
C0018681 (UMLS CUI-1)
Headache
Item
Headache?
boolean
C0018681 (UMLS CUI [1])
Item
Headache day
integer
C0018681 (UMLS CUI [1])
Headache day
Code List
Headache day
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Headache intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Headache Intensity
Code List
Headache intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing headache
Item
Ongoing after day 3?
boolean
C0018681 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last headache symptoms
Item
Date of last symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Item Group
Gastrointestinal symptoms
C0426576 (UMLS CUI-1)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms?
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms Day
integer
C0426576 (UMLS CUI [1])
Gastrointestinal symptoms Day
Code List
Gastrointestinal symptoms Day
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Gastrointestinal symptoms Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Gastrointestinal symptoms Intensity
Code List
Gastrointestinal symptoms Intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing Gastrointestinal symptoms
Item
Ongoing after day 3?
boolean
C0426576 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Gastrointestinal symptoms
Item
Date of last symptoms
date
C0011008 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
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