ID

36170

Descripción

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

Palabras clave

Versiones (1)
  1. 22/4/19 22/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Visit 4

1 formularios  
  1. StudyEvent: ODM
    1. Visit 4
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

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

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.
Descripción

Pharmaceutical Preparations

Tipo de datos

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).
Descripción

Human Papilloma Virus Vaccine

Tipo de datos

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.).
Descripción

Immunosuppressive Agents, chronic

Tipo de datos

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.
Descripción

Immunoglobulins; Blood Product

Tipo de datos

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.
Descripción

Laboratory Results, Human Papilloma Virus

Tipo de datos

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.
Descripción

Laboratory Results, Human Papillomavirus

Tipo de datos

boolean

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

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Descripción

Institution name, Identifier

Tipo de datos

integer

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

Patient date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
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 third visit of HPV-023 and the fourth 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
Colposcopy Information
Descripción

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?
Descripción

Yes, please complete the Colposcopysection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009417
Pelvic Examination
Descripción

Pelvic Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0030797
Has a history-directed 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
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 Specimen
Descripción

Repeated Cervical Specimen

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

Specimen, Cervical, Repeat

Tipo de datos

boolean

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

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?
Descripción

Specimen, Cervical, Repeat

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205064
UMLS CUI [1,3]
C0205341
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]
C0205341
UMLS CUI [1,4]
C0011008
Volver a la parte superior de la página

Similar models

Visit 4

1 formularios
  1. StudyEvent: ODM
    1. Visit 4
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial