Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Continuation status, Clinical Trials
Item
Did the subject return for visit 5?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
CL Item
Same reason and decision as previous visit. (1)
CL Item
Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (2)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (3)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation, ...) (4)
Item
Please tick who made the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who made the decision
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Serious Averse Event; Disease
Item
Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the fourth visit of HPV-023 and the fifth visit of HPV-023?
boolean
C1519255 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
Colposcopy
Item
Has a colposcopy been performed between the fourth visit of HPV-023 and the fifth visit of HPV-023 or directly related to cytology results from Visit 5?
boolean
C0009417 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken for HPV-16 and HPV-18 serology?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Physical Examination, Pelvis
Item
Has a woman's health (pelvic) examination been performed?
boolean
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Physical Examination, Pelvis, Date in time
Item
Date
date
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Gonococcal cervical swab, cervical swab test, Chlamydia swab
Item
Has a sample been taken for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) screening?
boolean
C1303035 (UMLS CUI [1,1])
C2266656 (UMLS CUI [1,2])
C0563467 (UMLS CUI [1,3])
Gonococcal cervical swab, cervical swab test, Chlamydia swab, Date in time
Item
Date
date
C1303035 (UMLS CUI [1,1])
C2266656 (UMLS CUI [1,2])
C0563467 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Specimen, Cervical
Item
Has a cervical specimen been collected?
boolean
C0370003 (UMLS CUI [1,1])
C0205064 (UMLS CUI [1,2])
Specimen, Cervical, Date in time
Item
Date
date
C0370003 (UMLS CUI [1,1])
C0205064 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Specimen, CervicalCytology, Repeat
Item
Has a repeated cervical specimen been collected?
boolean
C0370003 (UMLS CUI [1,1])
C0856201 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Specimen, Cervical, Repeat, Date in time
Item
Date
date
C0370003 (UMLS CUI [1,1])
C0856201 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Specimen, CervicalCytology, Repeat
Item
Has a repeated cervical specimen been collected?
boolean
C0370003 (UMLS CUI [1,1])
C0856201 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Specimen, Cervical, Repeat, Date in time
Item
Date
date
C0370003 (UMLS CUI [1,1])
C0856201 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Questionnaires
Item
Has the questionnaire been filled in?
boolean
C0034394 (UMLS CUI [1])