ID
36169
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-04-22 2019-04-22 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 april 2019
DOI
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Licens
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
- StudyEvent: ODM
Beskrivning
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event, Numbers
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Status of Treatment Blind
Alias
- UMLS CUI-1
- C2347038
- UMLS CUI-2
- C0449438
Beskrivning
Subject Unblinding Event Record
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
Subject Unblinding Event Record, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beskrivning
Subject Unblinding Event Record, Reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beskrivning
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Withdrawal
Alias
- UMLS CUI-1
- C2349954
Beskrivning
Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beskrivning
Withdraw, Reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0566251
Beskrivning
Withdraw, Decision
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
Beskrivning
Withdraw Date last contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beskrivning
Withdraw, Date last contact, General physical condition
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Cervical Colposcopy Diagram
Alias
- UMLS CUI-1
- C0009417
- UMLS CUI-2
- C0681494
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0009417
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0450429
- UMLS CUI [1,4]
- C0332307
Beskrivning
Use of Human Samples by GSK
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0457083
Beskrivning
Laboratory Procedures, Usage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0457083
Beskrivning
Laboratory Procedures, Storage, Duration
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C0449238
Beskrivning
Date in time, Consent Forms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Reason for Non-Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Beskrivning
Clinical Trial Subject Unique Identifier, Previous
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Beskrivning
Patient date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Unwilling, participation, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beskrivning
Unwilling, participation, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beskrivning
Date last contact
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Similar models
Study Conclusion
- 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])