ID

44254

Descripción

Study ID: 109616 (Y7) 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

Palabras clave

  1. 22/4/19 22/4/19 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

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Licencia

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

  1. StudyEvent: ODM
    1. Visit 3
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

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

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 3?
Descripción

Continuation status, Clinical Trials

Tipo de datos

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
Descripción

Continuation status, Clinical Trials, Reason

Tipo de datos

text

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

Continuation status, Clinical Trials, Decision

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Occurrence of Adverse Event
Descripción

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 second visit of HPV-023 and third visit of HPV-023?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0012634
Laboratory Tests - Blood Sample
Descripción

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?
Descripción

Collection of blood specimen for laboratory procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Date
Descripción

Please complete only if different from visit date

Tipo de datos

date

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

Woman's Health (Pelvic) Examination

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

Physical Examination, Pelvis

Tipo de datos

boolean

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

Please complete only if different from visit date

Tipo de datos

date

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

Collection of Cervical Swab

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

Gonococcal cervical swab, cervical swab test, Chlamydia swab

Tipo de datos

boolean

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

Please complete only if different from visit date

Tipo de datos

date

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

Cervical Specimen

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

Specimen, Cervical

Tipo de datos

boolean

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

Please complete only if different from visit date

Tipo de datos

date

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

Repeated Cervical Cytology Specimen

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

Specimen, CervicalCytology, Repeat

Tipo de datos

boolean

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

Pleasevcomplete only if different from visit date

Tipo de datos

date

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

Questionnaire

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

Questionnaires

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0034394

Similar models

  1. StudyEvent: ODM
    1. Visit 3
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 3?
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
CL Item
Investigator  (1)
CL Item
Subject (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 second visit of HPV-023 and third visit of HPV-023?
boolean
C1519255 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
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
Questionnaire
C0034394 (UMLS CUI-1)
Questionnaires
Item
Has the questionnaire been filled in?
boolean
C0034394 (UMLS CUI [1])

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