Englisch

GSK non-inferiority of Tritanrix Hepatitis B VISIT 2 NCT00290303

1 Formulare  
Reminder
Beschreibung

Reminder

Alias
UMLS CUI-1
C1709896
ELIMINATION CRITERIA
Beschreibung

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Beschreibung

drug or vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Beschreibung

immunosuppressants

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after.
Beschreibung

vaccine not foreseen

Datentyp

boolean

Alias
UMLS CUI [1]
C0042196
Administration of a meningococcal vaccine not foreseen in the protocol throughout the study period.
Beschreibung

meningococcal vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C0700144
Administration of immunoglobulins and/or any blood products during the study period.
Beschreibung

immunoglobulins blood products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0371802
Known hypersensitivity to any component of the vaccine.
Beschreibung

undefined item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
ADVERSE EVENTS
Beschreibung

ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
MEDICATION
Beschreibung

MEDICATION

Alias
UMLS CUI-1
C0013227
CONTRAINDICATIONS
Beschreibung

CONTRAINDICATIONS

CHECK FOR STUDY CONTINUATION
Beschreibung

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 2 ?
Beschreibung

Did the subject return for visit 2 ?

Datentyp

boolean

Alias
UMLS CUI [1]
C0545082
If no return because:
Beschreibung

no return

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
If no return because:
Beschreibung

no return other

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
UMLS CUI [1,3]
C0392360
Please tick who made the decision
Beschreibung

Decision

Datentyp

integer

Alias
UMLS CUI [1]
C0679006
LABORATORY TESTS
Beschreibung

LABORATORY TESTS

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Beschreibung

blood sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
VACCINE ADMINISTRATION
Beschreibung

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

integer

Maßeinheiten
  • c
Alias
UMLS CUI [1]
C0005903
c
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

integer

Alias
UMLS CUI [1]
C0005903
VACCINE ADMINISTRATION
Beschreibung

VACCINE ADMINISTRATION

Datentyp

integer

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

Side / Site Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0678813
Has the study vaccine been administered according to the Protocol?
Beschreibung

Has the study vaccine been administered according to the Protocol?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
Has the study vaccine been administered according to the Protocol? Side?
Beschreibung

Has the study vaccine been administered according to the Protocol?

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Has the study vaccine been administered according to the Protocol? Site?
Beschreibung

Has the study vaccine been administered according to the Protocol?

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205145
Has the study vaccine been administered according to the Protocol? Route?
Beschreibung

Has the study vaccine been administered according to the Protocol? Route?

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Why not administered?
Beschreibung

Why not administered?

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0392360
Why not administered? Other, please specify:
Beschreibung

Why not administered?

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1533734
Please tick who made the decision:
Beschreibung

Please tick who made the decision:

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0679006
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Beschreibung

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

Alias
UMLS CUI-1
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

signs/symptoms

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Redness
Beschreibung

Redness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Beschreibung

Redness

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
Redness intensity day 0
Beschreibung

Redness intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
Redness intensity day 1
Beschreibung

Redness intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
Redness intensity day 2
Beschreibung

Redness intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
Redness intensity day 3
Beschreibung

Redness intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Swelling
Beschreibung

Swelling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling Size
Beschreibung

Size Swelling

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
mm
Swelling intensity day 0
Beschreibung

Swelling intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0518690
Swelling intensity day 1
Beschreibung

Swelling intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0518690
Swelling intensity day 2
Beschreibung

Swelling intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0518690
Swelling intensity day 3
Beschreibung

Swelling intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0518690
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

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

Pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity
Beschreibung

Pain intensity

Datentyp

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 0
Beschreibung

Pain intensity day 0

Datentyp

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 1
Beschreibung

Pain intensity day 1

Datentyp

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 2
Beschreibung

Pain intensity day 2

Datentyp

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 3
Beschreibung

Pain intensity day 3

Datentyp

integer

Alias
UMLS CUI [1]
C3840282
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0030193
Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
Beschreibung

SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Beschreibung

signs/symptoms

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Fever
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever C°
Beschreibung

Fever

Datentyp

integer

Maßeinheiten
  • C°
Alias
UMLS CUI [1]
C0015967
C°
Fever intensity day 0
Beschreibung

Fever intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0522510
Fever intensity day 1
Beschreibung

Fever intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0522510
Fever intensity day 2
Beschreibung

Fever intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0522510
Fever intensity day 3
Beschreibung

Fever intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Beschreibung

Causality?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Site
Beschreibung

Site

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Irritability/ Fussiness
Beschreibung

Irritability

Datentyp

boolean

Alias
UMLS CUI [1]
C0022107
Irritability / Fussiness intensity day 0
Beschreibung

Irritability intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 1
Beschreibung

Irritability / Fussiness intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 2
Beschreibung

Irritability / Fussiness intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 3
Beschreibung

Irritability / Fussiness intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0011008
Causality?
Beschreibung

Causality?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0022107
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

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

Drowsiness

Datentyp

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity day 0
Beschreibung

Drowsiness intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 1
Beschreibung

Drowsiness intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 2
Beschreibung

Drowsiness intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 3
Beschreibung

Drowsiness intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0011008
Causality?
Beschreibung

Causality?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

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

Loss of appetite

Datentyp

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite intensity day 0
Beschreibung

Loss of appetite intensity day 0

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 1
Beschreibung

Loss of appetite intensity day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 2
Beschreibung

Loss of appetite intensity day 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 3
Beschreibung

Loss of appetite intensity day 3

Datentyp

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0011008
Causality?
Beschreibung

Causality?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
UNSOLICITED ADVERSE EVENTS
Beschreibung

UNSOLICITED ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Beschreibung

Unsolicited Adverse Events

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
concomitant vaccination
Beschreibung

concomitant vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beschreibung

vaccine

Datentyp

integer

Alias
UMLS CUI [1]
C0042210
Trade / (Generic) Name
Beschreibung

Trade / (Generic) Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Administration date
Beschreibung

Administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Concomitant medication
Beschreibung

Concomitant medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during study period?
Beschreibung

Medication

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
Trade / Generic Name
Beschreibung

Trade / Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Medical Indication
Beschreibung

Medical Indication

Datentyp

text

Alias
UMLS CUI [1]
C2315323
Medical Indication: Prophylactic?
Beschreibung

Prophylactic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
continuing
Beschreibung

continuing

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
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GSK non-inferiority of Tritanrix Hepatitis B VISIT 2 NCT00290303

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Reminder
C1709896 (UMLS CUI-1)
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
drug or vaccine
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1])
immunosuppressants
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
vaccine not foreseen
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
meningococcal vaccine
Item
Administration of a meningococcal vaccine not foreseen in the protocol throughout the study period.
boolean
C0700144 (UMLS CUI [1])
immunoglobulins blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
undefined item
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item Group
ADVERSE EVENTS
C0877248 (UMLS CUI-1)
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Item Group
CONTRAINDICATIONS
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for visit 2 ?
Item
Did the subject return for visit 2 ?
boolean
C0545082 (UMLS CUI [1])
Item
If no return because:
integer
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
no return
Code List
If no return because:
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify: (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
LABORATORY TESTS
C0022885 (UMLS CUI-1)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1])
Pre-Vaccination temperature
Code List
Pre-Vaccination temperature
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Item
VACCINE ADMINISTRATION
integer
C2368628 (UMLS CUI [1])
VACCINE ADMINISTRATION
Code List
VACCINE ADMINISTRATION
CL Item
Mencevax™ ACWY (full dose) (1)
CL Item
Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (5)
Item
Side / Site Route
integer
C0441987 (UMLS CUI [1,1])
C0678813 (UMLS CUI [1,2])
Side / Site Route
Code List
Side / Site Route
CL Item
Anterolateral (1)
CL Item
Left (2)
CL Item
Thigh (3)
CL Item
I.M. (4)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Has the study vaccine been administered according to the Protocol? Side?
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Code List
Has the study vaccine been administered according to the Protocol? Side?
CL Item
Left (1)
CL Item
Right (2)
Item
Has the study vaccine been administered according to the Protocol? Site?
integer
C2368628 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Code List
Has the study vaccine been administered according to the Protocol? Site?
CL Item
Deltoid (1)
CL Item
Tigh (2)
CL Item
Buttock (3)
Item
Has the study vaccine been administered according to the Protocol? Route?
integer
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol? Route?
Code List
Has the study vaccine been administered according to the Protocol? Route?
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Why not administered?
integer
C2368628 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Why not administered?
Code List
Why not administered?
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
Why not administered?
Item
Why not administered? Other, please specify:
text
C2368628 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Item
Please tick who made the decision:
integer
C2368628 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Please tick who made the decision:
Code List
Please tick who made the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1])
signs/symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (Information not available)
CL Item
No vaccine administered (No vaccine administered)
CL Item
No (No)
CL Item
Yes (Yes)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Redness intensity day 0
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Redness intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 1
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Redness intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 2
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Redness intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 3
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Redness intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
C0332575 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Size Swelling
Item
Swelling Size
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Item
Swelling intensity day 0
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Swelling intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 1
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Swelling intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 2
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Swelling intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 3
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Redness
Code List
Swelling intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (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])
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])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1])
Item
Pain intensity day 0
integer
C3840282 (UMLS CUI [1])
Redness
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
C3840282 (UMLS CUI [1])
Redness
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
C3840282 (UMLS CUI [1])
Redness
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
C3840282 (UMLS CUI [1])
Redness
Code List
Pain intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (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])
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
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Item Group
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1])
signs/symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever C°
integer
C0015967 (UMLS CUI [1])
Item
Fever intensity day 0
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fever intensity day 0
Code List
Fever intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 1
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fever intensity day 0
Code List
Fever intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 2
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fever intensity day 0
Code List
Fever intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 3
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fever intensity day 0
Code List
Fever intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0015967 (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])
Causality?
Item
Causality?
boolean
C0015127 (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])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Item
Site
integer
C1515974 (UMLS CUI [1])
Site
Code List
Site
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Irritability
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])
Redness
Code List
Irritability / Fussiness intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Irritability / Fussiness intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Irritability / Fussiness intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Irritability / Fussiness intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
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
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (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])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Drowsiness intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Drowsiness intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Drowsiness intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Drowsiness intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
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
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (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
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
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])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Loss of appetite intensity day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 1
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Loss of appetite intensity day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 2
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Loss of appetite intensity day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 3
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Redness
Code List
Loss of appetite intensity day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
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
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (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
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Item Group
UNSOLICITED ADVERSE EVENTS
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
integer
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
No (1)
CL Item
No vaccine administered (2)
CL Item
Information not available (3)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (4)
Item Group
concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
vaccine
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C0027365 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C2315323 (UMLS CUI [1])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
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])
continuing
Item
continuing
boolean
C1553904 (UMLS CUI [1])
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