ID

44256

Descrizione

Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Keywords

versioni (2)
  1. 22/04/19 22/04/19 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

20 settembre 2021

DOI

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Licenza

Creative Commons BY-NC 3.0
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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Inglese

Visit 5

1 moduli  
  1. StudyEvent: ODM
    1. Visit 5
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Clinical Trial Subject Unique Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Descrizione

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 5?
Descrizione

Continuation status, Clinical Trials

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
Descrizione

Continuation status, Clinical Trials, Reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who made the decision
Descrizione

Continuation status, Clinical Trials, Decision

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Demographics
Descrizione

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Descrizione

Institution name, Identifier

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Descrizione

Patient date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Gender
Descrizione

Gender

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Occurrence of Adverse Event
Descrizione

Occurrence of Adverse Event

Alias
UMLS CUI-1
C0877248
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?
Descrizione

Yes, please fill in Non-Serious Adverse Event section or the Serious Adverse Event report as necessary.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0012634
Colposcopy Information
Descrizione

Colposcopy Information

Alias
UMLS CUI-1
C0009417
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?
Descrizione

Yes, please complete the Colposcopy section

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009417
Laboratory Tests - Blood Sample
Descrizione

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken for HPV-16 and HPV-18 serology?
Descrizione

Collection of blood specimen for laboratory procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005834
Date
Descrizione

Please complete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Woman's Health (Pelvic) Examination
Descrizione

Woman's Health (Pelvic) Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0030797
Has a woman's health (pelvic) examination been performed?
Descrizione

Physical Examination, Pelvis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Date
Descrizione

Please complete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0011008
Collection of Cervical Swab
Descrizione

Collection of Cervical Swab

Alias
UMLS CUI-1
C2266656
Has a sample been taken for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) screening?
Descrizione

Gonococcal cervical swab, cervical swab test, Chlamydia swab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1303035
UMLS CUI [1,2]
C2266656
UMLS CUI [1,3]
C0563467
Date
Descrizione

Please complete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1303035
UMLS CUI [1,2]
C2266656
UMLS CUI [1,3]
C0563467
UMLS CUI [1,4]
C0011008
Cervical Specimen
Descrizione

Cervical Specimen

Alias
UMLS CUI-1
C0370003
UMLS CUI-2
C0205064
Has a cervical specimen been collected?
Descrizione

Specimen, Cervical

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
Date
Descrizione

Please complete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
UMLS CUI [1,3]
C0011008
Repeated Cervical Cytology Specimen
Descrizione

Repeated Cervical Cytology Specimen

Alias
UMLS CUI-1
C0370003
UMLS CUI-2
C0856201
UMLS CUI-3
C0205341
Has a repeated cervical specimen been collected?
Descrizione

Specimen, CervicalCytology, Repeat

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0856201
UMLS CUI [1,3]
C0205341
Date
Descrizione

Pleasevcomplete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0856201
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0011008
Second Repeated Cervical Specimen
Descrizione

Second Repeated Cervical Specimen

Alias
UMLS CUI-1
C0370003
UMLS CUI-2
C0205064
UMLS CUI-3
C0205341
Has a repeated cervical specimen been collected?
Descrizione

Specimen, CervicalCytology, Repeat

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0856201
UMLS CUI [1,3]
C0205341
Date
Descrizione

Pleasevcomplete only if different from visit date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0856201
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0011008
Questionnaire
Descrizione

Questionnaire

Alias
UMLS CUI-1
C0034394
Has the questionnaire been filled in?
Descrizione

Questionnaires

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0034394
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Similar models

Visit 5

1 moduli
  1. StudyEvent: ODM
    1. Visit 5
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
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])
Continuation status, Clinical Trials, Reason
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])
Continuation status, Clinical Trials, Reason
Code List
Please tick who made the decision
CL Item
Investigator  (1)
CL Item
Subject (2)
Item Group
Demographics
C1704791 (UMLS CUI-1)
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])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item Group
Occurrence of Adverse Event
C0877248 (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])
Item Group
Colposcopy Information
C0009417 (UMLS CUI-1)
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])
Item Group
Laboratory Tests - Blood Sample
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
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])
Item Group
Woman's Health (Pelvic) Examination
C0031809 (UMLS CUI-1)
C0030797 (UMLS CUI-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])
Item Group
Collection of Cervical Swab
C2266656 (UMLS CUI-1)
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])
Item Group
Cervical Specimen
C0370003 (UMLS CUI-1)
C0205064 (UMLS CUI-2)
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])
Item Group
Repeated Cervical Cytology Specimen
C0370003 (UMLS CUI-1)
C0856201 (UMLS CUI-2)
C0205341 (UMLS CUI-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])
Item Group
Second Repeated Cervical Specimen
C0370003 (UMLS CUI-1)
C0205064 (UMLS CUI-2)
C0205341 (UMLS CUI-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])
Item Group
Questionnaire
C0034394 (UMLS CUI-1)
Questionnaires
Item
Has the questionnaire been filled in?
boolean
C0034394 (UMLS CUI [1])
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