ID

36163

Description

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

Mots-clés

Versions (1)
  1. 22/4/19 22/4/19 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

22 de abril de 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Anglais

Visit 2

1 Formulaires  
  1. StudyEvent: ODM
    1. Visit 2
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

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

Check for Study Continuation

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

Continuation status, Clinical Trials

Type de données

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
Description

Continuation status, Clinical Trials, Reason

Type de données

text

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

Continuation status, Clinical Trials, Decision

Type de données

text

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

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 first visit of HPV-023 and second visit of HPV-023?
Description

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

Type de données

boolean

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

Colposcopy Information

Alias
UMLS CUI-1
C0009417
Has a colposcopy been performed between the first visit of HPV-023 and second visit of HPV-023?
Description

Yes, Please complete the Colposcopy Section

Type de données

boolean

Alias
UMLS CUI [1]
C0009417
Pelvic Examination
Description

Pelvic Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0030797
Has a history-directed pelvic examination been performed?
Description

Physical Examination, Pelvis

Type de données

boolean

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

Please complete only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0011008
Cervical Specimen
Description

Cervical Specimen

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

Specimen, Cervical

Type de données

boolean

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

Please complete only if different from visit date

Type de données

date

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

Repeated Cervical Specimen

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

Specimen, Cervical, Repeat

Type de données

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
UMLS CUI [1,3]
C0205341
Date
Description

Pleasevcomplete only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0011008
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Similar models

Visit 2

1 Formulaires
  1. StudyEvent: ODM
    1. Visit 2
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 2?
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
Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (2)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation, ...) (3)
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
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 first visit of HPV-023 and second 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 first visit of HPV-023 and second visit of HPV-023?
boolean
C0009417 (UMLS CUI [1])
Item Group
Pelvic Examination
C0031809 (UMLS CUI-1)
C0030797 (UMLS CUI-2)
Physical Examination, Pelvis
Item
Has a history-directed 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
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 Specimen
C0370003 (UMLS CUI-1)
C0205064 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Specimen, Cervical, Repeat
Item
Has a repeated cervical specimen been collected?
boolean
C0370003 (UMLS CUI [1,1])
C0205064 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Specimen, Cervical, Repeat, Date in time
Item
Date
date
C0370003 (UMLS CUI [1,1])
C0205064 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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