Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Temperature Log
Body Temperature Episode Number
Item
Episode Number
integer
temperature taken?
Item
Was temperature taken?
text
Day of Fever event
Item
Please record the day of fever/temperature event
text
Item
Type of measurement
text
Type of measurementBodyTemperature
Code List
Type of measurement
CL Item
Axillary (1)
CL Item
Rectal (2)
Temperature
Item
Temperature
float
If fever
Item
If the event matches the definition of fever, please record whether is was connected to the investigational product
boolean
medically attended visit
Item
Was the visit medically attended?
boolean
Item
If yes, record the type of medical involvement
text
medical involvement
Code List
If yes, record the type of medical involvement
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Reminder
If antipyretics or antibiotics -> Medication form
Item
If any antipyretics or antibiotics has been taken, please complete the Concomitant Medication section.
text
If FeverAfterSolicitedPeriod
Item
If fever occurs after the solicited period, please complete the Non-Serious Adverse Event sections.
text
Item Group
Rash / Exanthem
RashExanthema
Item
Has any rash / exanthem event occurred?
boolean
Item Group
Rash Event Log
Rash Episode Number
Item
Rash Episode Number
integer
Description
Item
Description
text
Item
Did rash occur at administration site of vaccine or non-administration site?
text
Administration Site
Code List
Did rash occur at administration site of vaccine or non-administration site?
CL Item
Administration site (1)
CL Item
Non-administration site (2)
Item
If administration site, please record the vaccine
text
AdministrationSiteVaccine
Code List
If administration site, please record the vaccine
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Item
If non-administration site, please record the site
text
If non-administration site, please record the site
Code List
If non-administration site, please record the site
CL Item
Generalized (1)
CL Item
Localized (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Rash intensity
text
Rash intensity
Code List
Rash intensity
CL Item
1-50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
Relationship to investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
medicallyAttendedVisit
Item
Was the visit medically attended?
boolean
Item
Please specify the type:
text
TypeMedicalAttendance
Code List
Please specify the type:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Parotid/Salivary Gland Swelling Events
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
Saliva sample
Item
Was saliva sample taken for mumps virus detection, strain identification and for viral culture?
boolean
Date sample taken
Item
Date sample taken
date
Causality
Item
Is there a reasonable possibility that the AE hay have been caused by the investigational product?
boolean
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
MedicallyAttendedVisit
Item
Was the visit medically attended?
boolean
Item
Please specify the type:
text
MedAttendanceType
Code List
Please specify the type:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Febrile Convulsions - Suspected Signs of Meningitis
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
NeurologicalExamination
Item
Was a neurological examination performed?
boolean
LumbarPuncturePerformed?
Item
If Yes, was a lumbar puncture performed?
boolean
MedRepostofLumbarPuncure
Item
If Yes, please attach a copy of Medical Report
text
Causality
Item
Is there a reasonable possibility that the AE hay have been caused by the investigational product?
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
MedicallyAttendedVisit
Item
Was the visit medically attended?
boolean
Item
Please specify the type:
text
MedAttendanceType
Code List
Please specify the type:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Concomitant Vaccination
ConcomitantVaccinationQuestion
Item
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Item Group
Concomitant Vaccination Details
Trade/Generic Name
Item
Trade/Generic Name
text
Item
Route
integer
Route
Code List
Route
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Unknown (11)
CL Item
Other (12)
Administration Date
Item
Administration Date
date
Item Group
Concomitant Medications
concomitant medications / treatments
Item
Have any medications / treatments been administered during the study period?
boolean
Item Group
Concomitant Medications Details
Trade/Genereic Name
Item
Trade/Genereic Name
text
ProphylacticAdministration
Item
Was the administration prophylactic?
boolean
Medical Indication
Item
Medical Indication
text
Total daily dose
Item
Total daily dose
text
Item
Route
integer
Route
Code List
Route
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Vaginal (11)
CL Item
Unknown (12)
CL Item
Other (13)
If Other, please specify
Item
If Other, please specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the event continuing?
boolean
Item Group
Non-Serious Adverse Events
AnyNon-SeriousAE
Item
Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
boolean
Item Group
Non-Serious Adverse Events Log
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Item
Was the Adverse Event at the administration site?
text
AdministrationSite
Code List
Was the Adverse Event at the administration site?
CL Item
administrationsite (1)
CL Item
non-administration site (2)
Item
Please record the vaccine
text
vaccine
Code List
Please record the vaccine
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
RelationshipToInvestigationalProducts
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, please specify type
text
MedAttendanceType
Code List
If Yes, please specify type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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