ID

25402

Beschreibung

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Stichworte

Versionen (2)
  1. 19.08.17 19.08.17 -
  2. 03.09.17 03.09.17 -
Hochgeladen am

3. September 2017

DOI

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Lizenz

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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

Englisch

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

1 Formulare  
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

study continuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Why didn't the subject return to visit 2?
Beschreibung

Please tick the ONE most appropriate reason and skip the following pages of this visit

Datentyp

text

Alias
UMLS CUI [1]
C2348568
SAE No
Beschreibung

Please specify number of SAE if that is the reason, why subject didn't return to visit 2.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Beschreibung

number of unsolicited adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
solicited AE code
Beschreibung

solicited AE code

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for not returning to visit 2.
Beschreibung

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Please tick who took the decision
Beschreibung

decision for study withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Laboratory tests
Beschreibung

Laboratory tests

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

Blood sample

Datentyp

integer

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Household exposure
Beschreibung

Household exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
Beschreibung

Exposure in household to varicella/zoster

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0020052
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0020052
Household exposure number
Beschreibung

Household exposure number

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
UMLS CUI-3
C0449788
Household Exposure No
Beschreibung

Household Exposure No

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
UMLS CUI [1,3]
C0449788
Date of onset exposure
Beschreibung

Date of onset exposure

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0332157
Type of exposure
Beschreibung

Type of exposure

Datentyp

integer

Alias
UMLS CUI [1]
C0332157
Varicella or zoster
Beschreibung

Varicella or zoster

Alias
UMLS CUI-1
C0008049
UMLS CUI-3
C0740380
Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
Beschreibung

if 'yes', please complete the Varicella or Zoster Case section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
How many episodes?
Beschreibung

Number of episodes of varicella/zoster signs and symptoms

Datentyp

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
Vaccine administration
Beschreibung

Vaccine administration

Alias
UMLS CUI-1
C2368628
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Beschreibung

anatomic site Temperature taken

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Vaccine administration
Beschreibung

Vaccine administration

Datentyp

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Beschreibung

Replacement vial

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Beschreibung

Wrong vial number

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Has the study vaccine been administered according to the Protocol?
Beschreibung

Protocol: Side: Left Site: Upper arm (Deltoid) Route: S.C.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
Side (vaccine administered)
Beschreibung

Only answer if vaccine wasn't administered according to protocol.

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0444532
UMLS CUI [1,3]
C0443246
Site (vaccine administered)
Beschreibung

Only answer if vaccine wasn't administered according to protocol.

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
Route (vaccine administered)
Beschreibung

Only answer if vaccine wasn't administered according to protocol.

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments (on vaccine administration)
Beschreibung

Comments on vaccine administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Date of vaccination
Beschreibung

fill in only if different from visit date

Datentyp

date

Alias
UMLS CUI [1]
C4301990
Why was the vaccine not administered?
Beschreibung

Please tick the ONE most appropriate category for non administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
SAE No
Beschreibung

Please specify number of SAE if that is the reason, why vaccine wasn't administered.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Beschreibung

number of unsolicited adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for non administration.
Beschreibung

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2368628
Unsolicited adverse event
Beschreibung

Unsolicited adverse event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
Beschreibung

non-serious unsolicited adverse event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231291
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0231291
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 signs/symptoms at the administration site during the solicited period?
Beschreibung

If Yes is ticked, please complete all following items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0851536
UMLS CUI [1,2]
C0037088
Redness
Beschreibung

Administration site erythema

Datentyp

boolean

Alias
UMLS CUI [1]
C3805283
Size (of redness at administration site) Day 0
Beschreibung

Size of erythema at administration site Day 0

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 1
Beschreibung

Size of erythema at administration site Day 1

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 2
Beschreibung

Size of erythema at administration site Day 2

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 3
Beschreibung

Size of erythema at administration site Day 3

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Ongoing after Day 3?
Beschreibung

Erythema ongoing after day 3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3805283
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]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Beschreibung

Administration site swelling

Datentyp

boolean

Alias
UMLS CUI [1]
C3854415
Size (of swelling at administration site) Day 0
Beschreibung

Size of swelling at administration site Day 0

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 1
Beschreibung

Size of swelling at administration site Day 1

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 2
Beschreibung

Size of swelling at administration site Day 2

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 3
Beschreibung

Size of swelling at administration site Day 3

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Ongoing after day 3?
Beschreibung

Swelling ongoing after day 3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3854415
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
Pain
Beschreibung

Administration site pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0521491
Intensity (of pain at administration site) Day 0
Beschreibung

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 1
Beschreibung

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 2
Beschreibung

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 3
Beschreibung

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Ongoing after day 3?
Beschreibung

Pain ongoing after day 3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521491
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]
C0030193
UMLS CUI [1,3]
C2700396
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 42 days post-vaccination 2?
Beschreibung

If Yes is ticked, please complete all following items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2368628
Fever
Beschreibung

≥37.5 °C axillary/≥38.0 °C rectal route If yes, please complete the Temperature section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C2368628
General rash / exanthema
Beschreibung

excluding varicella / zoster If yes, please complete the Rash / Exanthema section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C2368628
Parotid / salivary gland swelling
Beschreibung

If yes, please complete the Parotid / Salivary Gland Swelling section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C2368628
Febrile convulsions – suspected signs of meningism
Beschreibung

If yes, please complete the Febrile Convulsions – Suspected Signs of Meningism section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C0025287
UMLS CUI [2,2]
C2368628
Varicella / zoster
Beschreibung

If yes, please complete the Varicella / Zoster section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C2368628
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0039476
Route
Beschreibung

Direct measurement of axillary/ rectal temperature within 15 days post-vaccination 1. Only ONE route of temperature measurement should be used consistently for a given subject. Fever: Axillary: > 37.5°C Rectal: > 38.0°C

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0039476
Episode No
Beschreibung

Day 0 - 42

Datentyp

integer

Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • Degree Celsius
Alias
UMLS CUI [1]
C0039476
Degree Celsius
Not taken (Temperature)
Beschreibung

Temperature not taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0039476
Causality
Beschreibung

Only fill in if fever.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3641099
UMLS CUI [1,3]
C2368628
Medically attended Visit?
Beschreibung

Medically attended Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
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Ähnliche Modelle

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 2?
integer
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
study continuation
Code List
Did the subject return for visit 2?
CL Item
Yes, please complete the next pages. (1)
CL Item
No (2)
Item
Why didn't the subject return to visit 2?
text
C2348568 (UMLS CUI [1])
Why didn't the subject return to visit 2?
Code List
Why didn't the subject return to visit 2?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
solicited AE code
Item
solicited AE code
text
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for not returning to visit 2.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
decision for study withdrawal
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents / Guardians (P)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken?
integer
C0005834 (UMLS CUI [1])
Blood sample
Code List
Has a blood sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Household exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Exposure in household to varicella/zoster
Item
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
boolean
C0008049 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C0740380 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0020052 (UMLS CUI [2,3])
Item Group
Household exposure number
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Household Exposure No
Item
Household Exposure No
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Date of onset exposure
Item
Date of onset exposure
date
C0574845 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1])
Type of exposure
Code List
Type of exposure
CL Item
Varicella (1)
CL Item
Zoster (2)
Item Group
Varicella or zoster
C0008049 (UMLS CUI-1)
C0740380 (UMLS CUI-3)
signs or symptoms of varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
boolean
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Number of episodes of varicella/zoster signs and symptoms
Item
How many episodes?
integer
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
anatomic site Temperature taken
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
vaccine administered according to protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item
Side (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0444532 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
Side (vaccine administered)
Code List
Side (vaccine administered)
CL Item
Right (R)
CL Item
Left (L)
Item
Site (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site (vaccine administered)
Code List
Site (vaccine administered)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
Upper arm (Deltoid) (10)
CL Item
Lower arm (11)
Item
Route (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Route (vaccine administered)
Code List
Route (vaccine administered)
CL Item
i.m. (IM)
CL Item
s.c. (SC)
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Why was the vaccine not administered?
Code List
Why was the vaccine not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item Group
Unsolicited adverse event
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
text
C1519255 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
non-serious unsolicited adverse event
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
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 signs/symptoms at the administration site during the solicited period?
text
C0851536 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
signs or symptoms at administration site
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 (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Administration site erythema
Item
Redness
boolean
C3805283 (UMLS CUI [1])
Size of erythema at administration site Day 0
Item
Size (of redness at administration site) Day 0
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 1
Item
Size (of redness at administration site) Day 1
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 2
Item
Size (of redness at administration site) Day 2
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 3
Item
Size (of redness at administration site) Day 3
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Erythema ongoing after day 3
Item
Ongoing after Day 3?
boolean
C3805283 (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])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site swelling
Item
Swelling
boolean
C3854415 (UMLS CUI [1])
Size of swelling at administration site Day 0
Item
Size (of swelling at administration site) Day 0
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 1
Item
Size (of swelling at administration site) Day 1
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 2
Item
Size (of swelling at administration site) Day 2
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 3
Item
Size (of swelling at administration site) Day 3
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling ongoing after day 3
Item
Ongoing after day 3?
boolean
C3854415 (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])
Administration site pain
Item
Pain
boolean
C0521491 (UMLS CUI [1])
Intensity of pain at administration site Day 0
Item
Intensity (of pain at administration site) Day 0
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 1
Item
Intensity (of pain at administration site) Day 1
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 2
Item
Intensity (of pain at administration site) Day 2
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 3
Item
Intensity (of pain at administration site) Day 3
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Pain ongoing after day 3
Item
Ongoing after day 3?
boolean
C0521491 (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])
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 42 days post-vaccination 2?
text
C0037088 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
undefined item
Code List
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Fever after vaccine administration
Item
Fever
boolean
C0015967 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
General rash / exanthema after vaccine administration
Item
General rash / exanthema
boolean
C0015230 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
salivary gland swelling
Item
Parotid / salivary gland swelling
boolean
C0240925 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Febrile convulsions or suspected signs of meningism after vaccine administration
Item
Febrile convulsions – suspected signs of meningism
boolean
C0009952 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Varicella or Varicella zoster after vaccine administration
Item
Varicella / zoster
boolean
C0008049 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Item Group
Temperature
C0039476 (UMLS CUI-1)
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
temperature route
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item Group
Temperature
C0039476 (UMLS CUI-1)
Episode No
Item
Episode No
integer
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Temperature not taken
Item
Not taken (Temperature)
boolean
C0039476 (UMLS CUI [1])
Causality with vaccination fever
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
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