ID

36170

Beschrijving

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

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Versies (1)
  1. 22-04-19 22-04-19 -
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GlaxoSmithKline

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22 april 2019

DOI

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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

Engels

Visit 4

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 4
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Beschrijving

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) during the study period.
Beschrijving

Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
Administration of any HPV vaccine other than that used in HPV-001 (This will result in withdrawal from the study).
Beschrijving

Human Papilloma Virus Vaccine

Datatype

boolean

Alias
UMLS CUI [1]
C1512511
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Administration of inhaled and/or topical steroids is not considered a criterion that will influence a subject’s evaluability in the ATP cohorts.).
Beschrijving

Immunosuppressive Agents, chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of immunoglobulins and/or any blood products less than three months prior to blood sampling.
Beschrijving

Immunoglobulins; Blood Product

Datatype

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Receipt of the complete listings of HPV DNA results of cytology samples and/or biopsy samples from Study HPV-007.
Beschrijving

Laboratory Results, Human Papilloma Virus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0021344
Subjects who have received the HPV DNA results of the cytology samples and biopsy samples of HPV-007 cannot be enrolled in HPV-023.
Beschrijving

Laboratory Results, Human Papillomavirus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0021344
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beschrijving

Institution name, Identifier

Datatype

integer

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

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

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

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 third visit of HPV-023 and the fourth visit of HPV-023?
Beschrijving

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

Datatype

boolean

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

Colposcopy Information

Alias
UMLS CUI-1
C0009417
Has a colposcopy been performed between the third visit of HPV-023 but not directly related to cytology results from Visit 3 and fourth visit of HPV-023?
Beschrijving

Yes, please complete the Colposcopysection

Datatype

boolean

Alias
UMLS CUI [1]
C0009417
Pelvic Examination
Beschrijving

Pelvic Examination

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

Physical Examination, Pelvis

Datatype

boolean

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

Please complete only if different from visit date

Datatype

date

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

Cervical Specimen

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

Specimen, Cervical

Datatype

boolean

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

Please complete only if different from visit date

Datatype

date

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

Repeated Cervical Specimen

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

Specimen, Cervical, Repeat

Datatype

boolean

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

Please complete only if different from visit date

Datatype

date

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0011008
Second Repeated Cervical Specimen
Beschrijving

Second Repeated Cervical Specimen

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

Specimen, Cervical, Repeat

Datatype

boolean

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

Please complete only if different from visit date

Datatype

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 4

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 4
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) during the study period.
boolean
C0013227 (UMLS CUI [1])
Human Papilloma Virus Vaccine
Item
Administration of any HPV vaccine other than that used in HPV-001 (This will result in withdrawal from the study).
boolean
C1512511 (UMLS CUI [1])
Immunosuppressive Agents, chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Administration of inhaled and/or topical steroids is not considered a criterion that will influence a subject’s evaluability in the ATP cohorts.).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Immunoglobulins; Blood Product
Item
Administration of immunoglobulins and/or any blood products less than three months prior to blood sampling.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Laboratory Results, Human Papilloma Virus
Item
Receipt of the complete listings of HPV DNA results of cytology samples and/or biopsy samples from Study HPV-007.
boolean
C0022885 (UMLS CUI [1,1])
C0021344 (UMLS CUI [1,2])
Laboratory Results, Human Papillomavirus
Item
Subjects who have received the HPV DNA results of the cytology samples and biopsy samples of HPV-007 cannot be enrolled in HPV-023.
boolean
C1254595 (UMLS CUI [1,1])
C0021344 (UMLS CUI [1,2])
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 Adverse Event; Disease
Item
Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the third visit of HPV-023 and the fourth 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 third visit of HPV-023 but not directly related to cytology results from Visit 3 and fourth 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])
Item Group
Second Repeated Cervical Specimen
C0370003 (UMLS CUI-1)
C0205064 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Specimen, Cervical, Repeat
Item
Has a second 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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