Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
Item
Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
boolean
C0012634 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Ear and labyrinth (11)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Disease Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
Item
Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
boolean
C0005834 (UMLS CUI [1])
C0003241 (UMLS CUI [2])
C0021400 (UMLS CUI [3])
HI Antibody Determination Date
Item
HI Antibody Determination Date
date
C0003241 (UMLS CUI [1,1])
C0021400 (UMLS CUI [1,2])
C1148554 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Item
Temperatur measurement route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
Temperatur measurement route
CL Item
Rectal (not recommended) (R)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following pages) (N)
Replacement vial number
Item
Replacement vial number
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])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
Item
If study vaccine has not been administered according to the Protocol, specify Side
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [2])
Code List
If study vaccine has not been administered according to the Protocol, specify Side
Item
If study vaccine has not been administered according to the Protocol, specify Site
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
Code List
If study vaccine has not been administered according to the Protocol, specify Site
Item
If study vaccine has not been administered according to the Protocol, specify Route
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
Code List
If study vaccine has not been administered according to the Protocol, specify Route
Item
Please tick the major reason for non administration
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Please tick the major reason for non administration
CL Item
Serious adverse event (Please complete and submit SAE report) (SAE)
CL Item
Non-Serious adverse event (Please complete Non-Serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
Please specify SAE No.
Item
Please specify SAE No.
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Please specify AE No.
Item
Please specify AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify other reason for non administration
Item
Specify other reason for non administration
text
C1533734 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
Please tick who made decision (for non administration)
text
C0679006 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C1272696 (UMLS CUI [2,2])
Code List
Please tick who made decision (for non administration)