ID
36178
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)
- 22/4/19 22/4/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
22 de abril de 2019
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
Study Conclusion of Year 8
- StudyEvent: ODM
Descripción
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event, Numbers
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Status of Treatment Blind
Alias
- UMLS CUI-1
- C2347038
- UMLS CUI-2
- C0449438
Descripción
Subject Unblinding Event Record
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3897431
Descripción
Subject Unblinding Event Record, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
Subject Unblinding Event Record, Reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Descripción
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Withdrawal
Alias
- UMLS CUI-1
- C2349954
Descripción
Withdraw
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2349954
Descripción
Withdraw, Reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0566251
Descripción
Withdraw, Decision
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
Descripción
Withdraw Date last contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Descripción
Withdraw, Date last contact, General physical condition
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descripción
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator Signature, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Investigator Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Cervical Colposcopy Diagram
Alias
- UMLS CUI-1
- C0009417
- UMLS CUI-2
- C0681494
Descripción
L Leukoplakia W White Epithelium P Punctation M Mosaic V Atypical Vessels C Condyloma Po Polyp E Erosion/ Ulceration X Biopsy Sites I Invasive Carcinoma
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0009417
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0450429
- UMLS CUI [1,4]
- C0332307
Descripción
Use of Human Samples by GSK
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0457083
Descripción
Laboratory Procedures, Usage
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0457083
Descripción
Laboratory Procedures, Storage, Duration
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C0449238
Descripción
Date in time, Consent Forms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descripción
Investigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator Signature, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Investigator Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Reason for Non-Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Descripción
Clinical Trial Subject Unique Identifier, Previous
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Descripción
Patient date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Unwilling, participation, Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Descripción
Unwilling, participation, Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Descripción
Date last contact
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Similar models
Study Conclusion of Year 8
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0681494 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0457083 (UMLS CUI-2)
C0457083 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0009797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0205156 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])