ID

29348

Beschreibung

Visit 2 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

Stichworte

Versionen (1)
  1. 20.03.18 20.03.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

20. März 2018

DOI

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

Englisch

Visit 2, Month 1, 30 + 10 days after Visit 1, Dose 2

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschreibung

Subject Number

Datentyp

integer

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

Pre-vaccination assessment

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

Temperature

Datentyp

integer

Alias
UMLS CUI [1]
C0039476
Route
Beschreibung

Route

Datentyp

integer

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

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

Datentyp

boolean

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

Urine sample results, Pregnancy

Datentyp

integer

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

Vaccine administration

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

Vaccine administration

Datentyp

integer

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

Side / site Route

Datentyp

integer

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

Vaccine administration according to protocol

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Route

Datentyp

integer

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

Comments

Datentyp

text

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

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?
Beschreibung

Local symptoms

Datentyp

integer

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

Redness

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

Redness

Datentyp

boolean

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

Redness day

Datentyp

integer

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

Redness size

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Beschreibung

Ongoing redness

Datentyp

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:
Beschreibung

If you answered the previous question with yes, please specify

Datentyp

date

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

Swelling

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

Swelling

Datentyp

boolean

Alias
UMLS CUI [1]
C0038999
Swelling day
Beschreibung

Swelling day

Datentyp

integer

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

Swelling size

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Beschreibung

Ongoing swelling

Datentyp

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:
Beschreibung

If you answered the previous question with yes, please specify

Datentyp

date

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

Pain

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

Pain

Datentyp

boolean

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

Pain day

Datentyp

integer

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

Pain intensity

Datentyp

integer

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

Ongoing pain

Datentyp

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:
Beschreibung

If you answered the previous question with yes, please specify

Datentyp

date

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

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?
Beschreibung

General symptoms

Datentyp

integer

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

Fever

Alias
UMLS CUI-1
C0015967
Fever?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Route Fever
Beschreibung

Route

Datentyp

integer

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

Fever not taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever Day
Beschreibung

Fever Day

Datentyp

integer

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

Fever Day

Datentyp

integer

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

Temperature

Datentyp

integer

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Ongoing after day 3?
Beschreibung

Ongoing fever

Datentyp

boolean

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

Date of last fever symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Fatigue

Alias
UMLS CUI-1
C0015672
Fatigue?
Beschreibung

Fatigue

Datentyp

boolean

Alias
UMLS CUI [1]
C0015672
Day of fatigue
Beschreibung

Fatigue day

Datentyp

integer

Alias
UMLS CUI [1]
C0015672
Intensity of fatigue
Beschreibung

Fatigue intensity

Datentyp

integer

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

Ongoing fatigue

Datentyp

boolean

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

Date of last fatigue symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Headache

Alias
UMLS CUI-1
C0018681
Headache?
Beschreibung

Headache

Datentyp

boolean

Alias
UMLS CUI [1]
C0018681
Headache day
Beschreibung

Headache day

Datentyp

integer

Alias
UMLS CUI [1]
C0018681
Headache intensity
Beschreibung

Headache Intensity

Datentyp

integer

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

Ongoing headache

Datentyp

boolean

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

Date of last headache symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Gastrointestinal symptoms

Alias
UMLS CUI-1
C0426576
Gastrointestinal symptoms?
Beschreibung

Gastrointestinal symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms Day
Beschreibung

Gastrointestinal symptoms Day

Datentyp

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms Intensity
Beschreibung

Gastrointestinal symptoms Intensity

Datentyp

integer

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

Ongoing Gastrointestinal symptoms

Datentyp

boolean

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

Date of last Gastrointestinal symptoms

Datentyp

date

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

Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0426576
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Ähnliche Modelle

Visit 2, Month 1, 30 + 10 days after Visit 1, Dose 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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