Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Did the subject return for visit 2?
Item
Did the subject return for visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2])
If subject did not return for visit 2, please tick the ONE most appropriate reason
Code List
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non- Serious adverse event (complete the Non- serious Adverse Event form) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation,...) (OTH)
Please specify Serious Adverse Event
Item
Please specify Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Please specify Non- serious adverse event
Item
Please specify Non- serious adverse event
text
C2348235 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Specify other reason for subject didn't return for visit 2
Item
Specify other reason for subject didn't return for visit 2
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Please tick who took descision
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,4])
Please tick who took decision
Code List
Please tick who took descision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Item Group
Date of Birth
C0421451 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Large swelling reaction - Report of physical examination
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0549177 (UMLS CUI-3)
C0031809 (UMLS CUI-4)
1. Date of physical examination
Item
1. Date of physical examination
date
C2826643 (UMLS CUI [1])
Was the examination performed by a member of study personnel during the large swelling reaction period?
Item
Was the examination performed by a member of study personnel during the large swelling reaction period?
boolean
C0035173 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
2. Date when the swelling was first considered to be a large swelling reaction
Item
2. Date when the swelling was first considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
2.1 Specify how long after vaccination swelling occured
Item
2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
integer
C0038999 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
3. Size of swelling
Item
3. Size of swelling:
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
4. Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
4. Type of swelling
Code List
4. Type of swelling
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
5a. Circumference of swollen limb (at the site of maximum swelling):
Item
5a. Circumference of swollen limb (at the site of maximum swelling):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
5b. Circumference of the opposite limb (at the same level):
Item
5b. Circumference of the opposite limb (at the same level):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
6a. Associated signs
Item
6a. Associated signs - Temperature
float
C0037088 (UMLS CUI [1])
C0005903 (UMLS CUI [2])
Item
6a. Temperature measurement site
text
C0489453 (UMLS CUI [1])
6a. Temperature measurement site
Code List
6a. Temperature measurement site
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Typanic oral (X)
CL Item
Tympanic rectal (Y)
CL Item
Rectal (R)
6b. Redness
Item
6b. Redness
boolean
C0332575 (UMLS CUI [1])
6b. Largest diameter of Redness
Item
6b. Largest diameter of Redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6c. Induration
Item
6c. Induration
boolean
C0332534 (UMLS CUI [1])
6c. Induration largest diameter
Item
6c. Largest diameter of induration
integer
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6d. Pain at administration site
Item
6d. Pain at administration site
boolean
C0521491 (UMLS CUI [1])
Item
6d. Intensity of pain at administration site
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
6d. Intensity of pain at administration site
Code List
6d. Intensity of pain at administration site
CL Item
Grade 1 (Minor reaction to touch) (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limbs is moved / spontaneously painful (3)
6e. Functional impairment
Item
6e. Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
6e. Intensity of Functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
6e. Functional impairment
Code List
6e. Intensity of Functional impairment
CL Item
Grade 1 (Easily tolerated, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Grade 2 (Sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
Grade 3 (Prevents normal everyday activities) (3)
Item Group
Large swelling reaction - Clinical case desciption and outcome of the adverse event
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0549177 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C0205210 (UMLS CUI-5)
C1705586 (UMLS CUI-6)
7. Case description
Item
7. Case description
text
C0678257 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0868928 (UMLS CUI [1,3])
8. Last date when the swelling was still considered to be a large swelling reaction
Item
8. Last date when the swelling was still considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
8.1 If swelling lasting for less than 24 hours, please specify duration
Item
8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
9. Outcome of the large swellling reaction:
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
9. Outcome of the large swellling reaction
Code List
9. Outcome of the large swellling reaction:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered/ not resolved (please provide further follow- up data) (3)
CL Item
Recovered with sequelae / resolved with sequelae (please specify under section 7) (4)
10. Is there an alternative explanation for the swelling
Item
10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
10.1 Specify alternative explanation for the swelling
Item
10.1 Specify alternative explanation for the swelling.
text
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
undefined item
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0304229 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item Group
Concomitant Vaccination specification
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2348235 (UMLS CUI-3)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item
Route
text
C0013153 (UMLS CUI [1])
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)
Administration date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
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